[Tester av enhet som inte är godkänd eller godkänd av U.S. FDA] (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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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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, Förenta staterna, 85018
- Phoenix Cardiovascular Research Group
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California
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Burlingame, California, Förenta staterna, 94010
- Mills Peninsula Health Services
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Larkspur, California, Förenta staterna, 94939
- Cardiovascular Associates of Marin
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Newport Beach, California, Förenta staterna, 92663
- Hoag Memorial Hospital
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San Diego, California, Förenta staterna, 92123
- San Diego Cardiac Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, Förenta staterna, 32204
- Ascension St. Vincent's
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Jacksonville, Florida, Förenta staterna, 32207
- Baptist Health Research Institute
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Miami, Florida, Förenta staterna, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, Förenta staterna, 34102
- NCH Healthcare
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Orlando, Florida, Förenta staterna, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Förenta staterna, 30309
- Piedmont Healthcare
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Atlanta, Georgia, Förenta staterna, 30342
- Northside Hospital
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Savannah, Georgia, Förenta staterna, 31404
- Memorial Health University Medical Center
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Illinois
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Glenview, Illinois, Förenta staterna, 60026
- NorthShore University Medical Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham And Women's Hospital
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Michigan
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Royal Oak, Michigan, Förenta staterna, 48073
- Beaumont Health Systems
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55414
- Minneapolis Heart Institute
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New Jersey
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Morristown, New Jersey, Förenta staterna, 07960
- Morristown Medical Center
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87102
- New Mexico Heart Institute
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New York
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New York, New York, Förenta staterna, 10029
- Mount Sinai School of Medicine
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New York, New York, Förenta staterna, 10075
- Lenox Hill Hospital
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New York, New York, Förenta staterna, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Roslyn, New York, Förenta staterna, 11576
- St Francis Hospital
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The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center
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North Carolina
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Raleigh, North Carolina, Förenta staterna, 27610
- WakeMed Heart & Vascular
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania Health System
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York, Pennsylvania, Förenta staterna, 17403
- York Hospital
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Texas
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Austin, Texas, Förenta staterna, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Houston, Texas, Förenta staterna, 77030
- Texas Heart Institute
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Utah
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Murray, Utah, Förenta staterna, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, Förenta staterna, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
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Norfolk, Virginia, Förenta staterna, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BWI202303
- BWI202303 (Annan identifierare: Biosense Webster, Inc.)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
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