[Prøving av enhet som ikke er godkjent eller godkjent 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Adelaide, Australia, 5000
- Royal Adelaide Hospital
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Parkville, Australia, 03052
- Royal Melbourne Hospital
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Arizona
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Phoenix, Arizona, Forente stater, 85018
- Phoenix Cardiovascular Research Group
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California
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Burlingame, California, Forente stater, 94010
- Mills Peninsula Health Services
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Larkspur, California, Forente stater, 94939
- Cardiovascular Associates of Marin
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Newport Beach, California, Forente stater, 92663
- Hoag Memorial Hospital
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San Diego, California, Forente stater, 92123
- San Diego Cardiac Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado
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Connecticut
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Hartford, Connecticut, Forente stater, 06102
- Hartford Hospital
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Florida
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Jacksonville, Florida, Forente stater, 32204
- Ascension St. Vincent's
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Jacksonville, Florida, Forente stater, 32207
- Baptist Health Research Institute
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Miami, Florida, Forente stater, 33133
- HCA Florida Mercy Hospital
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Naples, Florida, Forente stater, 34102
- NCH Healthcare
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Orlando, Florida, Forente stater, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Forente stater, 30309
- Piedmont Healthcare
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Atlanta, Georgia, Forente stater, 30342
- Northside Hospital
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Savannah, Georgia, Forente stater, 31404
- Memorial Health University Medical Center
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Illinois
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Glenview, Illinois, Forente stater, 60026
- NorthShore University Medical Center
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General
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Boston, Massachusetts, Forente stater, 02115
- Brigham And Women's Hospital
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Michigan
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Royal Oak, Michigan, Forente stater, 48073
- Beaumont Health Systems
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55414
- Minneapolis Heart Institute
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New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Morristown Medical Center
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87102
- New Mexico Heart Institute
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New York
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New York, New York, Forente stater, 10029
- Mount Sinai School of Medicine
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New York, New York, Forente stater, 10075
- Lenox Hill Hospital
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New York, New York, Forente stater, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Roslyn, New York, Forente stater, 11576
- St Francis Hospital
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The Bronx, New York, Forente stater, 10467
- Montefiore Medical Center
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North Carolina
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Raleigh, North Carolina, Forente stater, 27610
- WakeMed Heart & Vascular
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Health System
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York, Pennsylvania, Forente stater, 17403
- York Hospital
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Texas
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Austin, Texas, Forente stater, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Houston, Texas, Forente stater, 77030
- Texas Heart Institute
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Utah
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Murray, Utah, Forente stater, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, Forente stater, 22042
- Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
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Norfolk, Virginia, Forente stater, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, Forente stater, 23298
- Virginia Commonwealth University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants with Primary Adverse Events (PAEs)
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BWI202303
- BWI202303 (Annen identifikator: Biosense Webster, Inc.)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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