[Proef met een apparaat dat niet is goedgekeurd of goedgekeurd door de Amerikaanse 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Adelaide, Australië, 5000
- Royal Adelaide Hospital
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Parkville, Australië, 03052
- Royal Melbourne Hospital
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85018
- Phoenix Cardiovascular Research Group
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California
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Burlingame, California, Verenigde Staten, 94010
- Mills Peninsula Health Services
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Larkspur, California, Verenigde Staten, 94939
- Cardiovascular Associates of Marin
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Newport Beach, California, Verenigde Staten, 92663
- Hoag Memorial Hospital
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San Diego, California, Verenigde Staten, 92123
- San Diego Cardiac Center
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado
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Connecticut
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Hartford, Connecticut, Verenigde Staten, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, Verenigde Staten, 32204
- Ascension St. Vincent's
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Jacksonville, Florida, Verenigde Staten, 32207
- Baptist Health Research Institute
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Miami, Florida, Verenigde Staten, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, Verenigde Staten, 34102
- NCH Healthcare
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Orlando, Florida, Verenigde Staten, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Verenigde Staten, 30309
- Piedmont Healthcare
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Atlanta, Georgia, Verenigde Staten, 30342
- Northside Hospital
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Savannah, Georgia, Verenigde Staten, 31404
- Memorial Health University Medical Center
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Illinois
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Glenview, Illinois, Verenigde Staten, 60026
- NorthShore University Medical Center
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Massachusetts General
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Boston, Massachusetts, Verenigde Staten, 02115
- Brigham And Women's Hospital
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Michigan
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Royal Oak, Michigan, Verenigde Staten, 48073
- Beaumont Health Systems
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55414
- Minneapolis Heart Institute
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New Jersey
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Morristown, New Jersey, Verenigde Staten, 07960
- Morristown Medical Center
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
- New Mexico Heart Institute
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New York
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New York, New York, Verenigde Staten, 10029
- Mount Sinai School of Medicine
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New York, New York, Verenigde Staten, 10075
- Lenox Hill Hospital
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New York, New York, Verenigde Staten, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Roslyn, New York, Verenigde Staten, 11576
- St Francis Hospital
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The Bronx, New York, Verenigde Staten, 10467
- Montefiore Medical Center
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North Carolina
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Raleigh, North Carolina, Verenigde Staten, 27610
- WakeMed Heart & Vascular
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania Health System
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York, Pennsylvania, Verenigde Staten, 17403
- York Hospital
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Texas
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Austin, Texas, Verenigde Staten, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Houston, Texas, Verenigde Staten, 77030
- Texas Heart Institute
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Utah
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Murray, Utah, Verenigde Staten, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, Verenigde Staten, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
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Norfolk, Virginia, Verenigde Staten, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Verenigde Staten, 23298
- Virginia Commonwealth University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
Tijdsspanne: 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
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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
Tijdsspanne: Day 91 to Day 365 post-procedure
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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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Tijdsspanne: Baseline, Month 12
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BWI202303
- BWI202303 (Andere identificatie: Biosense Webster, Inc.)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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