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    Summary
    EudraCT Number:2021-004457-23
    Sponsor's Protocol Code Number:29BRC21.0255
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-004457-23
    A.3Full title of the trial
    Impact of local tissue inflammation on intramyocardial conduction pathways post percutaneous valve : evaluation by positron emission tomography
    Impact de l’inflammation tissulaire locale sur les voies de conduction intra-myocardique post valve percutanée : évaluation par tomographie à émission de positons
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of local tissue inflammation on intramyocardial conduction pathways post percutaneous valve : evaluation by positron emission tomography
    Impact de l’inflammation tissulaire locale sur les voies de conduction intra-myocardique post valve percutanée : évaluation par tomographie à émission de positons
    A.3.2Name or abbreviated title of the trial where available
    IMPACT
    IMPACT
    A.4.1Sponsor's protocol code number29BRC21.0255
    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 SponsorCHU de Brest
    B.1.3.4CountryFrance
    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 supportCHU de Brest
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Brest
    B.5.2Functional name of contact pointMenez
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Foch
    B.5.3.2Town/ cityBrest
    B.5.3.3Post code29609
    B.5.3.4CountryFrance
    B.5.4Telephone number+33229020089
    B.5.5Fax number+33298223183
    B.5.6E-mailtiphaine.menez@chu-brest.fr
    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 FLUDESOXYGLUCOSE (18F)-CURIUM
    D.2.1.1.2Name of the Marketing Authorisation holderCURIUM INTERNATIONAL
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameFLUDESOXYGLUCOSE (18F)-CURIUM
    D.3.2Product code FDG Scan ( 18F) 185 MBq/mL
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 Yes
    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
    Aortic stenosis
    TAVI
    Cardiac conduction disorders
    Pacemaker
    Rétrécissement aortique serré
    TAVI
    Troubles de conduction cardiaque
    Stimulateur cardiaque
    E.1.1.1Medical condition in easily understood language
    Aortic stenosis
    TAVI
    Cardiac conduction disorders
    Pacemaker
    Rétrécissement aortique serré
    TAVI
    Troubles de conduction cardiaque
    Stimulateur cardiaque
    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 10050559
    E.1.2Term Aortic valve calcification
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10077015
    E.1.2Term Transcatheter aortic valve implantation
    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
    The primary objective of the study is to investigate the association between the occurrence of conduction disturbances after percutaneous aortic valve and the degree of inflammation of the intramyocardial conduction pathways assessed by PET scan.
    L’objectif principal de l’étude est d’étudier l’association entre la survenue de troubles de conduction après valve aortique percutanée et le degré d’inflammation des voies de conduction intra-myocardique évalué par TEP scanner.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - To investigate the association between the degree of intramyocardial conduction pathway inflammation assessed by PET scan and the need for pacemaker implantation after percutaneous aortic valve.
    - To identify predictive factors of pacemaker dependence at 1 and 6 months.
    Les objectifs secondaires de l’étude sont :
    − Etudier l’association entre le degré d’inflammation des voies de conduction intra-myocardique évalué par TEP scanner et la nécessité d’implantation de pacemaker après valve aortique percutanée.
    − Identification de facteurs prédictifs de dépendance au pacemaker à 1 et 6 mois.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Major patient (>18 years of age);
    - Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR transvalvular peak velocity ≥ 4 m/s OR transvalvular mean gradient ≥ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest;
    - Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction < 50% ;
    - Patient with vascular anatomy compatible with percutaneous femoral valve implantation;
    - Patient majeur (> 18 ans) ;
    - Patient présentant un rétrécissement aortique serré défini par une surface valvulaire aortique ≤ 1cm2 (ou une surface valvulaire aortique indexée ≤ 0.6 cm2/m2 de surface corporelle), OU par une vitesse maximale transvalvulaire ≥ 4 m/s OU un gradient moyen transvalvulaire ≥ 40 mmHg, évalué par une échocardiographie transthoracique (ETT) réalisée chez un patient au repos ;
    - Patient symptomatique avec : dyspnée ≥ stade 2 selon la classification de la New-York Heart Association (NYHA) OU épreuve d’effort pathologique avec apparition de symptômes à l’effort, d’une chute tensionnelle ou de trouble du rythme à l’effort OU Asymptomatique avec Fraction d’Ejection du Ventricule Gauche (FEVG) < 50% ;
    - Patient ayant une anatomie vasculaire compatible avec une implantation percutanée de la valve par voie fémorale ;
    E.4Principal exclusion criteria
    - Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation;
    - Patient with a uni or bicuspid aortic valve;
    - Patient with severe left ventricular dysfunction LVEF < 30%;
    - Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis ;
    - Patient with iliofemoral vascular anatomy preventing safe passage of the valve;
    - Patient with a pre-existing bioprosthesis or mechanical prosthesis at TAVI in any position;
    - Inability or refusal to consent;
    - Pregnant or breastfeeding woman;
    - Patient under guardianship or curatorship;
    - Patient with life expectancy < 12 months.
    - Patient appareillé d’un stimulateur cardiaque ou d’un défibrillateur triple chambre avant l’implantation du TAVI ;
    - Patient présentant une valve aortique uni ou bicuspide ;
    - Patient avec dysfonction ventriculaire gauche sévère FEVG < 30% ;
    - Patient présentant d’autres valvulopathies significatives : insuffisance aortique ≥ grade 3, insuffisance mitrale ≥ grade 3 ou rétrécissement mitral serré ;
    - Patient avec une anatomie vasculaire ilio-fémorale empêchant le passage en toute sécurité de la valve ;
    - Patient porteur d’une bioprothèse ou d’une prothèse mécanique pré existante au TAVI, dans n’importe quelle position ;
    - Incapacité ou refus de donner son consentement ;
    - Femme enceinte ou allaitante ;
    - Patient sous tutelle ou curatelle ;
    - Patient ayant une espérance de vie < 12 mois .
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is "occurrence of conductive disturbance": 1) complete BAV, 2) high-grade BAV, 3) LBBB, 4) RBBB, 5) BAV1; assessed by the performance of post-percutaneous valve implantation electrocardiograms (ECGs) during the initial patient's hospitalization.
    Le critère de jugement principal est la « survenue d’un trouble conductif » intra-hospitalier, critère composite comportant : 1) le BAV complet, 2) les BAV de haut grade, 3) le BBG, 4) le BBD, 5) le BAV1 ; évalué par la réalisation, au cours de l’hospitalisation initiale, d’électrocardiogrammes (ECG) post implantation de valve percutané.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the initial patient's hospitalization
    Pendant la durée d'hospitalisation initiale du patient
    E.5.2Secondary end point(s)
    − Post-TAVI pacemaker implantation
    − Post-TAVI PM dependence at 1 month, 6 months (binary criterion of dependence and simulation rate)
    − "Occurrence of a conductive disorder" within 6 months of discharge from TAVI's hospitalization.
    − Implantation d’un pacemaker en post-TAVI
    − Dépendance à un pacemaker post-TAVI à 1 mois, 6 mois (critère binaire de dépendance et taux de simulation)
    − « Survenue d’un trouble conductif » dans les 6 mois suivant la sortie de l’hospitalisation de pose de TAVI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the initial patient's hospitalization, 1 month, and 6 months postpercutaneous valve implantation.
    Pendant la durée d'hospitalisation initiale du patient, 1 mois et 6 mois post implantation de valve percutanée.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    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)
    It is the same as the normal treatment of that condition
    Identique à la prise en charge habituelle
    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 Decision2022-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-11
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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