[Test mit einem Gerät, das nicht von der US-amerikanischen FDA zugelassen oder freigegeben ist] (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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Adelaide, Australien, 5000
- Royal Adelaide Hospital
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Parkville, Australien, 03052
- Royal Melbourne Hospital
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85018
- Phoenix Cardiovascular Research Group
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California
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Burlingame, California, Vereinigte Staaten, 94010
- Mills Peninsula Health Services
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Larkspur, California, Vereinigte Staaten, 94939
- Cardiovascular Associates of Marin
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Newport Beach, California, Vereinigte Staaten, 92663
- Hoag Memorial Hospital
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San Diego, California, Vereinigte Staaten, 92123
- San Diego Cardiac Center
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado
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Connecticut
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Hartford, Connecticut, Vereinigte Staaten, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32204
- Ascension St. Vincent's
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Jacksonville, Florida, Vereinigte Staaten, 32207
- Baptist Health Research Institute
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Miami, Florida, Vereinigte Staaten, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, Vereinigte Staaten, 34102
- NCH Healthcare
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Orlando, Florida, Vereinigte Staaten, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Vereinigte Staaten, 30309
- Piedmont Healthcare
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Northside Hospital
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Savannah, Georgia, Vereinigte Staaten, 31404
- Memorial Health University Medical Center
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Illinois
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Glenview, Illinois, Vereinigte Staaten, 60026
- NorthShore University Medical Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21287
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham And Women's Hospital
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Michigan
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Royal Oak, Michigan, Vereinigte Staaten, 48073
- Beaumont Health Systems
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55414
- Minneapolis Heart Institute
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New Jersey
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Morristown, New Jersey, Vereinigte Staaten, 07960
- Morristown Medical Center
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New Mexico
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Albuquerque, New Mexico, Vereinigte Staaten, 87102
- New Mexico Heart Institute
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New York
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New York, New York, Vereinigte Staaten, 10029
- Mount Sinai School of Medicine
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New York, New York, Vereinigte Staaten, 10075
- Lenox Hill Hospital
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New York, New York, Vereinigte Staaten, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Roslyn, New York, Vereinigte Staaten, 11576
- St Francis Hospital
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The Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Medical Center
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North Carolina
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Raleigh, North Carolina, Vereinigte Staaten, 27610
- WakeMed Heart & Vascular
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- University of Pennsylvania Health System
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York, Pennsylvania, Vereinigte Staaten, 17403
- York Hospital
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Texas
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Austin, Texas, Vereinigte Staaten, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Houston, Texas, Vereinigte Staaten, 77030
- Texas Heart Institute
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Utah
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Murray, Utah, Vereinigte Staaten, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, Vereinigte Staaten, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
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Norfolk, Virginia, Vereinigte Staaten, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Vereinigte Staaten, 23298
- Virginia Commonwealth University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BWI202303
- BWI202303 (Andere Kennung: Biosense Webster, Inc.)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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