[Essai d'un dispositif qui n'est pas approuvé ou autorisé par la FDA américaine] (OMNY-AF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Adelaide, Australie, 5000
- Royal Adelaide Hospital
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Parkville, Australie, 03052
- Royal Melbourne Hospital
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Arizona
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Phoenix, Arizona, États-Unis, 85018
- Phoenix Cardiovascular Research Group
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California
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Burlingame, California, États-Unis, 94010
- Mills Peninsula Health Services
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Larkspur, California, États-Unis, 94939
- Cardiovascular Associates of Marin
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Newport Beach, California, États-Unis, 92663
- Hoag Memorial Hospital
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San Diego, California, États-Unis, 92123
- San Diego Cardiac Center
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado
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Connecticut
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Hartford, Connecticut, États-Unis, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, États-Unis, 32204
- Ascension St. Vincent's
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Jacksonville, Florida, États-Unis, 32207
- Baptist Health Research Institute
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Miami, Florida, États-Unis, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, États-Unis, 34102
- NCH Healthcare
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Orlando, Florida, États-Unis, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, États-Unis, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, États-Unis, 30309
- Piedmont Healthcare
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Atlanta, Georgia, États-Unis, 30342
- Northside Hospital
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Savannah, Georgia, États-Unis, 31404
- Memorial Health University Medical Center
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Illinois
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Glenview, Illinois, États-Unis, 60026
- NorthShore University Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General
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Boston, Massachusetts, États-Unis, 02115
- Brigham And Women's Hospital
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Michigan
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Royal Oak, Michigan, États-Unis, 48073
- Beaumont Health Systems
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55414
- Minneapolis Heart Institute
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New Jersey
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Morristown, New Jersey, États-Unis, 07960
- Morristown Medical Center
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- New Mexico Heart Institute
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New York
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New York, New York, États-Unis, 10029
- Mount Sinai School of Medicine
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New York, New York, États-Unis, 10075
- Lenox Hill Hospital
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New York, New York, États-Unis, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Roslyn, New York, États-Unis, 11576
- St Francis Hospital
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The Bronx, New York, États-Unis, 10467
- Montefiore Medical Center
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North Carolina
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Raleigh, North Carolina, États-Unis, 27610
- WakeMed Heart & Vascular
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania Health System
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York, Pennsylvania, États-Unis, 17403
- York Hospital
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Texas
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Austin, Texas, États-Unis, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Houston, Texas, États-Unis, 77030
- Texas Heart Institute
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Utah
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Murray, Utah, États-Unis, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, États-Unis, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
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Norfolk, Virginia, États-Unis, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Diagnosed with symptomatic paroxysmal AF with:
- At least two symptomatic AF episodes within last six months from enrollment
- At least one electrocardiographically documented AF episode within twelve months prior to enrollment
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Failed at least one Class I or Class III antiarrhythmic drug
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Willing and capable to provide consent
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Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion Criteria:
- Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF
- Patients known to require ablation outside the PV ostia and outside the CTI region.
- Documented severe dilatation of the left atrium (LAD>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
- Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
- Documented severely compromised left ventricular ejection fraction (LVEF <40%) by imaging within 6 months prior to enrollment
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
- Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction [MI] within the past 2 months
- Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
- Valvular cardiac surgical/percutaneous procedure
- Unstable angina within 6 months
- Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Prior diagnosis of pulmonary vein stenosis
- Pre-existing hemi diaphragmatic paralysis
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Severe mitral regurgitation
- Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
- Presence of a condition that precludes vascular access
- Current enrollment in an investigational study evaluating another device or drug
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- Life expectancy less than 12 months
- Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Pulsed Field (PF) Ablation System
Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure. |
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
Délai: 7 days post-procedure
|
Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis. |
7 days post-procedure
|
|
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes
Délai: Day 91 to Day 365 post-procedure
|
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of >= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported. |
Day 91 to Day 365 post-procedure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Délai: Baseline, Month 12
|
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms. |
Baseline, Month 12
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BWI202303
- BWI202303 (Autre identifiant: Biosense Webster, Inc.)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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