A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Biosense Webster, Inc.
Study ID
NCT06455098
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • OMNYPULSE™ Catheter with the TRUPULSE Generator — DEVICE
    OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.

Study Details

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.

Key Dates

Start date
Jun 28, 2024
Status verified
Mar 2026
Primary completion
May 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
440 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants with Primary Adverse Events (PAEs) [ Time Frame: 7 days post-procedure ]

Central Contacts

Locations (43)

FacilityCityStateZIPSite coordinators
Phoenix Cardiovascular Research GroupPhoenixArizona85018-
Mills Peninsula Health ServicesBurlingameCalifornia94010-
Scripps Clinic/Prebys Cardiovascular InstituteLa JollaCalifornia92037-
Cardiovascular Associates of MarinLarkspurCalifornia94939-
Loma Linda Medical CenterLoma LindaCalifornia92354-
Hoag Memorial HospitalNewport BeachCalifornia92663-
San Diego Cardiac CenterSan DiegoCalifornia92123-
California Pacific Medical Center- Sutter HealthSan FranciscoCalifornia94109-
Providence Saint John s Health CenterSanta MonicaCalifornia90404-
University of ColoradoAuroraColorado80045-
Hartford HospitalHartfordConnecticut06102-
Ascension St. Vincent'sJacksonvilleFlorida32204-
Baptist Health Research InstituteJacksonvilleFlorida32207-
HCA Florida Mercy HospitalMiamiFlorida33133-
NCH HealthcareNaplesFlorida34102-
Advent Health OrlandoOrlandoFlorida32803-
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Northside HospitalAtlantaGeorgia30342-
Piedmont HealthcareAtlantaGeorgia30309-
Memorial Health University Medical CenterSavannahGeorgia31404-
NorthShore University Medical CenterGlenviewIllinois60026-
Johns HopkinsBaltimoreMaryland21287-
Brigham And Women's HospitalBostonMassachusetts02115-
Massachusetts GeneralBostonMassachusetts02114-
Beaumont Health SystemsRoyal OakMichigan48073-
Minneapolis Heart InstituteMinneapolisMinnesota55414-
Morristown Medical CenterMorristownNew Jersey07960-
New Mexico Heart InstituteAlbuquerqueNew Mexico87102-
Lenox Hill HospitalNew YorkNew York10075-
Mount Sinai School of MedicineNew YorkNew York10029-
New York Presbyterian - Weill Cornell Medical CtrNew YorkNew York10065-
St Francis HospitalRoslynNew York11576-
Montefiore Medical CenterThe BronxNew York10467-
WakeMed Heart & VascularRaleighNorth Carolina27610-
Cleveland ClinicClevelandOhio44195-
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
York HospitalYorkPennsylvania17403-
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
Texas Heart InstituteHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-
Inova Fairfax Medical Campus- Inova Heart and Vascular InstituteFalls ChurchVirginia22042-
Sentara Norfolk General HospitalNorfolkVirginia23507-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Phoenix, AZ

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Phoenix Cardiovascular Research Group· Phoenix, AZMills Peninsula Health Services· Burlingame, CAScripps Clinic/Prebys Cardiovascular Institute· La Jolla, CACardiovascular Associates of Marin· Larkspur, CALoma Linda Medical Center· Loma Linda, CAHoag Memorial Hospital· Newport Beach, CA

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