Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Biosense Webster, Inc.
Study ID
NCT03683030
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Multi-Electrode RF Balloon Catheter — DEVICE
    Multi-Electrode RF Balloon Catheter will be inserted

Study Details

The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

Key Dates

Start date
Oct 22, 2018
Status verified
Oct 2025
Primary completion
Feb 18, 2022
Completion
Feb 18, 2022

Study Design

Enrollment
397 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    Ablation using Multi-electrode Radiofrequency (RF) Balloon Catheter (HELIOSTAR).

Primary Outcome Measure

Number of Participants With Any Primary Adverse Events (PAE) That Occurred Within 7 Days Following Atrial Fibrillation (AF) Ablation Procedure Using HELIOSTAR Catheter [ Time Frame: Within 7 days post-procedure (Day of procedure = Day 0) ]

Locations (37)

FacilityCityStateZIPSite coordinators
Phoenix Cardiovascular Research GroupPhoenixArizona85018-
University of Southern CaliforniaLos AngelesCalifornia90033-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92618-
Mercy General HospitalSacramentoCalifornia95819-
University Of Colorado Anschutz Medical CampusAuroraColorado80045-
Med Center of the RockiesLovelandColorado80538-
Yale New Haven HospitalNew HavenConnecticut06520-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Baptist Health Research InstituteJacksonvilleFlorida32207-
AdventHealth OrlandoOrlandoFlorida32804.-
Emory St Joseph's HospitalAtlantaGeorgia30342-
Piedmont HospitalAtlantaGeorgia30309-
Northwestern Memorial HospitalChicagoIllinois60611-
University of Kansas Medical CenterKansas CityKansas66160-
Kansas City Arrhythmia ResearchOverland ParkKansas66215-
The Johns Hopkins HospitalBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Spectrum Health SystemGrand RapidsMichigan49503-
Mayo ClinicRochesterMinnesota55905-
Saint Luke's Hospital of Kansas CityKansas CityMissouri92618-
Morristown Medical CenterMorristownNew Jersey07960-
The Valley HospitalRidgewoodNew Jersey07450-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Lenox Hill Hospital - Northwell HealthNew YorkNew York10075-
The Ohio State UniversityColumbusOhio43210-
Kettering Medical CenterKetteringOhio45429-
Oklahoma HeartTulsaOklahoma74101-
Doylestown HospitalDoylestownPennsylvania18901-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Trident Medical CenterCharlestonSouth Carolina29406-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
CHI Baylor St. Lukes Medical CenterHoustonTexas77030-
Baylor Scott & White The Heart Hospital - PlanoPlanoTexas75093-
Methodist Texsan HospitalSan AntonioTexas78201-
Inova Health Care ServicesFalls ChurchVirginia22042-
Swedish Medical CenterSeattleWashington98122-

Find similar trials in Phoenix, AZ

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Phoenix Cardiovascular Research Group· Phoenix, AZUniversity of Southern California· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAMercy General Hospital· Sacramento, CAUniversity Of Colorado Anschutz Medical Campus· Aurora, COMed Center of the Rockies· Loveland, CO

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