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    Summary
    EudraCT Number:2015-002516-33
    Sponsor's Protocol Code Number:NCT01420393
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-08
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-002516-33
    A.3Full title of the trial
    A Randomized Ablation-based atrial Fibrillation rhythm control versus rate control Trial in patients with heart failure and high burden Atrial Fibrillation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The RAFT-AF study will examine two options for managing atrial fibrillation in heart failure patients. The two treatment options are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and to try to maintain the heart in sinus rhythm.
    A.3.2Name or abbreviated title of the trial where available
    RAFT-AF
    A.4.1Sponsor's protocol code numberNCT01420393
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01420393
    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 SponsorUniversity of Ottawa Heart Institute
    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 Institutes of Health Research
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Ottawa Heart Institute
    B.5.2Functional name of contact pointraftaf@ottawaheart.ca
    B.5.3 Address:
    B.5.3.1Street Address40 Ruskin Street
    B.5.3.2Town/ cityOttawa
    B.5.3.3Post codeK4A3B2
    B.5.3.4CountryCanada
    B.5.4Telephone number16137615442
    B.5.6E-mailraftaf@ottawaheart.ca
    D. IMP Identification
    D.IMP: 1
    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 Anticoagulants Antiplatelet agents Angiotensin-Converting Enzyme Inhibitors Angiotensin II Receptor Blockers Beta Blockers Combined alpha and beta-blockers Calcium Channel Blockers Digitalis Diuretics Vasodilators
    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 nameCardiovascular Medication
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    The study is comparing two accepted treatment methods (rhythm control-Catheter ablation with or without anti-arrhythmic drug control of maintaining sinus rhythm versus rate controls with medical therapy &/or atrio-ventricular junction ablation and pacemaker treatment for atrial fibrillation) in patients with high burden atrial fibrillation and heart failure. This trial will enrol a total of 600 patients and patients will be randomized in a 1:1 ration to each treatment arm
    E.1.1.1Medical condition in easily understood language
    This study is comparing treatment of atrial fibrillation in heart failure patients by maintaining sinus rhythm or controlling the heart rate in partial fibrillation in these patients
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if rhythm treatment of AF by catheter ablation, with or without antiarrhythmic drug will reduce all-cause mortality and hospitalizations for heart failure defined as an admission to a health care facility for > 24 hours as compared with rate control in patients with HF (either impaired or preserved LV function) and high burden AF.
    E.2.2Secondary objectives of the trial
    To determine in patients with HF (either impaired or preserved LV function) and high burden AF: 1) if catheter ablation-based AF rhythm control will reduce all-cause mortality, CV mortality or hospitalizations for heart failure as compared with rate control in patients 2) if catheter ablation-based AF rhythm control provide better QOL and exercise capacity than rate control, 3) if catheter ablation-based AF rhythm control is a cost effective treatment approach compared with rate control, 4) In patients with HF and impaired LV function, if catheter-based AF rhythm treatment reduces all-cause mortality and hospitalizations for heart failure compared with rate control; in patients with HF and preserved LV function, if catheter-based AF rhythm treatment reduces all-cause mortality and hospitalizations for heart failure compared with rate control, 5) If catheter ablation-based AF rhythm control in HF patients is safe?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with one of the following AF categories and at least one ECG documentation of AF:
    a) High burden Paroxysmal defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode > 6 hours (and no other episodes that required CV or was > 7 days)
    b) Persistent AF (1) defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode > 6 hours, and at least one AF episode less than 7 days but requires cardioversion. No AF episodes are > 7 days
    c) Persistent AF (2) as defined by at least one episode of AF > 7 days but not > 1 year
    d) Long term persistent AF defined as an AF episode, at least one year in length and no episode > 3 years
    2. Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
    3. Heart Failure with NYHA class II or III symptoms with either impaired LV function (LVEF lessthan or equal to 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF > 45%) as determined by EF assessment within the previous 12 months
    4. An elevated N-terminal pro brain natriuretic peptide (NT-proBNP) defined as:
    A) Patient has been hospitalized for Heart Failure* in the past 9 months, has been discharged AND:
    i- Is presently in Normal Sinus Rhythm and NT-pro BNP is ≥ 400 pg/mL or
    ii- Is presently in Atrial Fibrillation and NT-pro BNP is ≥ 600 pg/mL
    OR
    B) Patient has had no hospitalization for Heart Failure in the past 9 months AND:
    i- Has had paroxysmal Atrial Fibrillation, is presently in Normal Sinus Rhythm and NT-proBNP is ≥ 600 pg/mL or
    ii- Is presently in Atrial Fibrillation and NT-proBNP is ≥ 900 pg/mL

    *Heart Failure Admission is defined as admission to hospital > 24 hours and received treatment for Heart failure

    5. Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
    6. Age ≥18
    E.4Principal exclusion criteria
    1. Have an LA dimension > 55 mm as determined by an echocardiography within the previous year
    2. Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
    3. Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
    4. Have congenital heart disease including previous ASD repair, persistent left superior vena cava
    5. Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
    6. Have a medical condition likely to limit survival to < 1 year
    7. Have New York Heart Association (NYHA) class IV heart failure symptoms
    8. Have contraindication to systematic anticoagulation
    9. Have renal failure requiring dialysis
    10. AF due to reversible cause e.g. hyperthyroid state
    11. Are pregnant
    12. Are included in other clinical trials that will affect the objectives of this study
    13. Have a history of non-compliance to medical therapy
    14. Are unable or unwilling to provide informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Composite of all-cause mortality and hospitalization for heart failure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient accruement is scheduled for three years with a minimum follow up of 24 months
    E.5.2Secondary end point(s)
    All-cause mortality, CV mortality, All-cause hospitalization, HF hospitalization, CV hospitalization, Health economics, QOL – MLWHF, EQ5D, AFEQT, 6 minute walk distance and CCS-SAF scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient accruement is scheduled for three years with a minimum follow up of 24 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Rhythm Control Catheter Ablation for Atrial Fibrillation
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Canada
    Taiwan
    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
    LVSL
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 600
    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)
    None
    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 Decision2015-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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