[Prova di un dispositivo non approvato o autorizzato dalla FDA statunitense] (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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Adelaide, Australia, 5000
- Royal Adelaide Hospital
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Parkville, Australia, 03052
- Royal Melbourne Hospital
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-
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Arizona
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Phoenix, Arizona, Stati Uniti, 85018
- Phoenix Cardiovascular Research Group
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California
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Burlingame, California, Stati Uniti, 94010
- Mills Peninsula Health Services
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Larkspur, California, Stati Uniti, 94939
- Cardiovascular Associates of Marin
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Newport Beach, California, Stati Uniti, 92663
- Hoag Memorial Hospital
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San Diego, California, Stati Uniti, 92123
- San Diego Cardiac Center
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- University of Colorado
-
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Connecticut
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Hartford, Connecticut, Stati Uniti, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, Stati Uniti, 32204
- Ascension St. Vincent's
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Jacksonville, Florida, Stati Uniti, 32207
- Baptist Health Research Institute
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Miami, Florida, Stati Uniti, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, Stati Uniti, 34102
- NCH Healthcare
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Orlando, Florida, Stati Uniti, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Stati Uniti, 30309
- Piedmont Healthcare
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Atlanta, Georgia, Stati Uniti, 30342
- Northside Hospital
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Savannah, Georgia, Stati Uniti, 31404
- Memorial Health University Medical Center
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Illinois
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Glenview, Illinois, Stati Uniti, 60026
- NorthShore University Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins
-
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham And Women's Hospital
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Michigan
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Royal Oak, Michigan, Stati Uniti, 48073
- Beaumont Health Systems
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55414
- Minneapolis Heart Institute
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New Jersey
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Morristown, New Jersey, Stati Uniti, 07960
- Morristown Medical Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- New Mexico Heart Institute
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New York
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New York, New York, Stati Uniti, 10029
- Mount Sinai School of Medicine
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New York, New York, Stati Uniti, 10075
- Lenox Hill Hospital
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New York, New York, Stati Uniti, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Roslyn, New York, Stati Uniti, 11576
- St Francis Hospital
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The Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center
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North Carolina
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Raleigh, North Carolina, Stati Uniti, 27610
- WakeMed Heart & Vascular
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania Health System
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York, Pennsylvania, Stati Uniti, 17403
- York Hospital
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Texas
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Austin, Texas, Stati Uniti, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Houston, Texas, Stati Uniti, 77030
- Texas Heart Institute
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Utah
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Murray, Utah, Stati Uniti, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, Stati Uniti, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
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Norfolk, Virginia, Stati Uniti, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Stati Uniti, 23298
- Virginia Commonwealth University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BWI202303
- BWI202303 (Altro identificatore: Biosense Webster, Inc.)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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