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    Summary
    EudraCT Number:2016-002353-38
    Sponsor's Protocol Code Number:OHIRC-20150866
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2016-11-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-002353-38
    A.3Full title of the trial
    The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
    Optimale Antikoagulation nach Katheterablation von Vorhofflimmern bei Patienten mit erhöhtem Schlaganfallrisiko
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimal anticoagulation for patients with an increased risk for stroke after treatment of an heart arrhythmia (atrial fibrillation) by catheter ablation
    Optimale Gerinnungshemmung für Patienten mit einem erhöhten Risiko für Schlaganfall nach der Behandlung der Herzarrhythmie Vorhofflimmern durch Katheterablation
    A.3.2Name or abbreviated title of the trial where available
    OCEAN
    A.4.1Sponsor's protocol code numberOHIRC-20150866
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02168829
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOttawa Heart Institute Research Corporation (OHIRC)
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCanadian Institute for Health Research
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportBiotronik Inc.
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportBayer Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKompetenznetz Vorhofflimmern e.V.
    B.5.2Functional name of contact pointLegal Sponsor Representative
    B.5.3 Address:
    B.5.3.1Street AddressMendelstr. 11
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number492519801340
    B.5.5Fax number492519801349
    B.5.6E-mailocean@af-net.eu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXarelto
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name acetylsalicylic acid of any trade name
    D.2.1.1.2Name of the Marketing Authorisation holderany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameacetylsalicylic acid
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameASA, ASS
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 160
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    risk of stroke by atrial fibrillation
    durch Vorhofflimmern erhöhtes Schlaganfallrisiko
    E.1.1.1Medical condition in easily understood language
    increased risk for stroke by atrial fibrillation, a heart arrhythmia
    durch Vorhofflimmern (eine Arrhythmie des Herzen) erhöhtes Risiko für Schlaganfall
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10014498
    E.1.2Term Embolic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059864
    E.1.2Term Cardiac ablation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This phase 4 trial investigates whether a strategy of ongoing, long-term oral anticoagulation is superior to a strategy of antiplatelet therapy (ASA) alone in reducing the incidence of cerebral embolic events in moderate risk patients post-successful catheter ablation for atrial fibrillation.
    Diese Phase 4-Studie untersucht, ob eine Strategie mit andauernder, langfristigen oralen Antikoagulation einer Strategie mit Thrombozytenaggregationshemmern (ASS) überlegen ist in der Reduktion von zerebralen, embolischen Ereignissen bei Patienten mit einem moderaten Risiko nach erfolgreicher Katheterablation bei Vorhofflimmern.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial are the evaluation of
    - efficacy of rivaroxaban and ASA, respectively, in the reduction of the incidence of stroke, systemic embolism or silent cerebral infarction
    - safety of long-term oral anticoagulation after catheter ablation for atrial fibrillation
    - cost effectiveness of long-term oral anticoagulation after catheter ablation for atrial fibrillation
    - relationship of the atrial fibrillation burden to stroke risk
    Sekundäre Ziele der Studie sind die Untersuchung
    - der Effizienz von Rivaroxaban oder ASS in der Reduktion von Schlaganfällen, systemischer Embolie oder stillen Hirninfarkten
    - der Sicherheit von Langzeit-Antikoagulation nach Katheterablation bei Vorhofflimmern
    - der Kosteneffizienz einer Langzeitbehandlung mit oraler Antikoagulation nach Katheterablation bei Vorhofflimmern
    - des Zusammenhangs von der Belastung mit Vorhofflimmern und dem Schlaganfallrisiko
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be at least one year post-successful catheter ablation(s) for atrial fibrillation without evidence of any clinically apparent arrhythmia recurrence defined as all of the following:
    No AF/AT/AFL on at least 24 hour Holter and an ECG (or equivalent) from 2-6 months after the last ablation,
    AND no AF/AT/AFL on at least 24 hour Holter and an ECG any time after 6 months after the last ablation
    AND no AF/AT/AFL on at least 24 hour Holter and ECG 2 months before enrolment in the study. The Holter/ECG within 2 months of enrolment may also serve as the Holter performed 6 months or later after the last ablation - see section 2.3.1 for details.
    2. Patient must have a CHA2DS2-VASc risk score of 1 or more. Patients in whom female sex or vascular disease are their sole risk factor may not be enrolled.
    3. Patient must be >18 years of age.
    4. Patient must have non-valvular AF.
    1. Der Patient muss vor mehr als einem Jahr eine erfolgreiche Katheterablation(en) bei Vorhofflimmern gehabt haben, ohne nachweisbares Auftreten von klinisch auffälligen Arrhythmien, definiert durch alle folgenden Kriterien:
    Kein Vorhofflimmern/Vorhoftachykardie/Vorhofflattern in einem Langzeit-EKG über mindestens 24 Stunden und einem EKG 2-6 Monate nach der letzten Ablation,
    UND kein Vorhofflimmern/Vorhoftachykardie/Vorhofflattern in einem Langzeit-EKG über mindestens 24 Stunden und einem EKG nach mindestens 6 Monaten nach der letzten Ablation
    UND kein Vorhofflimmern/Vorhoftachykardie/Vorhofflattern in einem Langzeit-EKG über mindestens 24 Stunden und einem EKG 2 Monate vor Einschluss in die Studie. Das Langzeit-EKG/EKG 2 Monate vor Einschluss kann ebenfalls das EKG nach mind. 6 Monaten sein - siehe Abschnitt 2.3.1.
    2. Der Patient muss einen CHA2DS2-VASc Risiko-Score von 1 oder mehr aufweisen. Patienten, bei denen das weibliche Geschlecht oder eine Gefäßerkrankung den einzigen Risikofaktor darstellen, müssen einen zusätzlichen Risikofaktor haben.
    3. Der Patient muss über 18 Jahre alt sein.
    4. Der Patient muss nicht-valvuläres Vorhofflimmern haben.
    E.4Principal exclusion criteria
    1. Patient does not meet all of the above listed inclusion criteria.
    2. Patient is unable or unwilling to provide informed consent.
    3. Patient is included in another randomized clinical trial or a clinical trial requiring an insurance.
    4. Patient has been on an investigational drug within 30 days of enrolment.
    5. Patient has been on strong CYP3A inducers (such as rifampicin, phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors (such as ketoconazole or protease inhibitors) within 4 days of enrolment.
    6. Patient has creatinine clearance < 30 mL/min.
    7. Patient has bleeding contra-indication to oral anticoagulation (such as bleeding diathesis, hemorrhagic disorder, significant gastrointestinal bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding history, fibrinolysis within 48 hours of enrollment).
    8. Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent (such as allergy).
    9. Patient has a contraindication to magnetic resonance imaging (MRI) or is unlikely to tolerate due to severe claustrophobia.
    10. Patients with a contraindication to implantation of an implantable loop recorder if the patient opts for loop recorder as part of the
    study (such as limited immunocompetence or a wound healing disorder).
    11. Patient has valvular atrial fibrillation [reference AHA guidelines].
    12. Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
    13. Patient had a severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
    14. Patient with special risk factors for stroke unrelated to AF, specifically known thrombophilia/ hypercoagulability, uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease.
    15. Pregnancy or breastfeeding.
    16. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study.
    17. Patients who are > 85 years of age.
    18. Patients who are critically ill or who have a life expectancy <3 years.
    19. Patients for whom the investigator believes that the trial is not in the interest of the patient.
    1. Patient erfüllt nicht alle oben genannten Einschlusskriterien.
    2. Fehlende Einwilligung zur Studienteilnahme oder nicht gegebene Einwilligungsfähigkeit des Patienten.
    3. Teilnahme des Patienten an einer anderen randomisierten, klinischen Studie oder einer anderen versicherungspflichtigen Studie.
    4. Der Patient hat in den letzten 30 Tagen vor Einschluss ein Prüfpräparat eingenommen.
    5. Der Patient hat in den letzten 4 Tagen vor Einschluss starke Induktoren oder Inhibitoren von CYP3A (wie Rifampicin, Phenytoin, Phenobarbital oder Carbamazepin) eingenommen.
    6. Der Patient hat eine Kreatinin-Clearance < 30 mL/min.
    7. Patient hat wegen Blutungsrisikos eine Kontraindikation für eine orale Antikoagulation (wie Blutungsneigung, hämorrhagische Störung, signifikante gastrointestinale Blutungen in den letzten 6 Monaten, intrakranielle/ intraokulare/atraumatische Blutungsanamnese, Fibrinolyse in den letzten 48 Stunden vor Einschluss)
    8. Der Patient hat andere Kontraindikationen zur oralen Antikoagulation oder zu der Behandlung mit Thrombozytenhemmern (wie eine Allergie).
    9. Der Patient hat eine Kontraindikation zur Durchführung einer Magnetresonanztomographie (MRT) oder es ist unwahrscheinlich, dass er diese aufgrund einer starken Klaustrophobie toleriert.
    10. Der Patient hat valvuläres Vorhofflimmern (Referenz AHA Leitlinien).
    11. Der Patient hat einen nicht durch Arrhythmie bedingten Zustand, der Langzeit-Antikoagulation erfordert.
    12. Der Patient hatte einen schweren, invalidisierenden Schlaganfall innerhalb des letzten Jahres vor Einschluss oder jeglichen Schlaganfall in den letzten 14 Tagen vor Einschluss.
    13. Patienten mit speziellen Risikofaktoren für Schlaganfall unabhängig von Vorhofflimmern, insbesondere bekannte Thrombophilie/Hyperkoagulabilität, unkontrollierter Blut-hochdruck, (systolischer Blutdruck >180 mmHg und/oder diastolischer Blutdruck >100 mmHg in den letzten 4 Tagen vor Einschluss), unbehandelte familiäre Hyperlipidämie, bekannte vaskuläre Anomalie (intrakranielles Aneurysma/arteriovenöse Fehlbildung oder chronische vaskuläre Gefäßdissektion) oder bekannte schwere Erkrankung der Carotis.
    14. Schwangerschaft oder Stillen.
    15. Frauen im gebärfähigen Alter, die sich weigern, eine hocheffiziente und medizinisch akzeptable Form der Verhütung für die Dauer der Studie anzuwenden.
    16. Patienten über >85 Jahre.
    17. Patienten mit einem kritischen Krankheitszustand oder einer Lebenserwartung von <3 Jahren.
    18. Patienten, bei denen der Prüfer der Meinung ist, dass die Studie nicht im Interesse des Patienten ist.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is a composite of stroke, systemic embolism, and covert embolic stroke as defined by assessment of cerebral magnetic resonance imaging.
    Der primäre Endpunkt setzt sich zusammen aus Schlaganfall, systemischer Embolie und stillem embolischen Schlaganfall, definiert durch Auswertung der zerebrale Magnetresonanztomographie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated for the primary endpoint at follow up visits at 6, 12, 24 and 36 months with an MRI being performed at Baseline and 36 months for detection of covert stroke.
    Die Patienten werden bei den Visiten nach 6, 12, 24 und 36 Monaten auf den primären Endpunkt hin untersucht, wobei in MRTs zur Baseline und nach 36 Monaten stillen Schlaganfällen gesucht wird.
    E.5.2Secondary end point(s)
    1. Clinical, overt stroke
    2. Incidence of one or more covert MRI stroke(s) > 15 mm
    3. Composite of all major and minor bleeding
    4. Major bleeding only
    5. Minor bleeding only
    6. Intracranial hemorrhage
    7. Transient ischemic attack
    8. All-cause mortality
    9. Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events
    10. Occurrence of non-primary endpoint MRI changes from baseline to final scan
    11. Neuropsychological testing
    12. Quality of life assessment
    13. Cost utilization and cost effectiveness analysis
    1. Klinisch manifester Schlaganfall
    2. Inzidenz von einem oder mehreren stillen Schlaganfällen >15 mm.
    3. Zusammengesetzt aus allen schweren und leichten Blutungen.
    4. Nur schwere Blutung
    5. Nur leichte Blutung
    6. Intrakranielle Blutung
    7. Transiente ischämische Attacke (TIA)
    8. Gesamtmortalität
    9. Klinischer Netto-Nutzen basierend auf der Reduktion von Schlaganfall/TIA verglichen mit schweren Blutungen
    10. Auftreten von MRT-Veränderungen im finalen MRT gegenüber dem Baseline-MRT, die nicht primärer Endpunkt sind
    11. Neuropsychologische Tests
    12. Beurteilung der Lebensqualität
    13. Analyse der Kostennutzung und Kosteneffizienz
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated for endpoints at follow up visits at 6, 12, 24 and 36 months with an MRI being performed at Baseline and 36 months for detection of covert stroke.
    Die Patienten werden bei den Visiten nach 6, 12, 24 und 36 Monaten auf die Endpunkte hin untersucht, wobei in MRTs zur Baseline und nach 36 Monaten stillen Schlaganfällen gesucht wird.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    Israel
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last MRI of the last patient
    Letztes MRT des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state375
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 1572
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated according to the general treatment guidelines for atrial fibrillation or other concomitant diseases they might have according to the assessment of their attending physician. This treatment will not be different from patients who had not participated in the OCEAN study.
    Patienten erhalten ihre Behandlung entprechend der Richtlinien für Vorhofflimmern oder andere möglichen Begleiterkrankungen nach Einschätzung ihres behandelnden Arztes. Diese Behandlung unterscheidet sich nicht von der, die Patienten erhalten, die nicht an der OCEAN Studie teilgenommen haben.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-31
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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