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

PHASE3CompletedINTERVENTIONAL
Enrollment

397

Participants

Timeline

Start Date

October 22, 2018

Primary Completion Date

February 18, 2022

Study Completion Date

February 18, 2022

Conditions
Atrial Fibrillation
Interventions
DEVICE

Multi-Electrode RF Balloon Catheter

Multi-Electrode RF Balloon Catheter will be inserted

Trial Locations (41)

10029

Icahn School of Medicine at Mount Sinai, New York

10075

Lenox Hill Hospital - Northwell Health, New York

15213

University of Pittsburgh Medical Center, Pittsburgh

18901

Doylestown Hospital, Doylestown

20010

MedStar Washington Hospital Center, Washington D.C.

21287

The Johns Hopkins Hospital, Baltimore

22042

Inova Health Care Services, Falls Church

29406

Trident Medical Center, Charleston

30309

Piedmont Hospital, Atlanta

30342

Emory St Joseph's Hospital, Atlanta

32207

Baptist Health Research Institute, Jacksonville

37232

Vanderbilt University Medical Center, Nashville

43210

The Ohio State University, Columbus

45429

Kettering Medical Center, Kettering

49503

Spectrum Health System, Grand Rapids

55905

Mayo Clinic, Rochester

60611

Northwestern Memorial Hospital, Chicago

66160

University of Kansas Medical Center, Kansas City

66215

Kansas City Arrhythmia Research, Overland Park

74101

Oklahoma Heart, Tulsa

75093

Baylor Scott & White The Heart Hospital - Plano, Plano

77030

CHI Baylor St. Lukes Medical Center, Houston

78201

Methodist Texsan Hospital, San Antonio

78705

Texas Cardiac Arrhythmia Research Foundation, Austin

80045

University Of Colorado Anschutz Medical Campus, Aurora

80538

Med Center of the Rockies, Loveland

85018

Phoenix Cardiovascular Research Group, Phoenix

90033

University of Southern California, Los Angeles

92618

Hoag Memorial Hospital Presbyterian, Newport Beach

Saint Luke's Hospital of Kansas City, Kansas City

95819

Mercy General Hospital, Sacramento

98122

Swedish Medical Center, Seattle

200025

Ruijin Hospital, Rui Jin Er Road

310020

Sir Run Run Shaw Hospital, Hangzhou

06520

Yale New Haven Hospital, New Haven

32804.

AdventHealth Orlando, Orlando

02114

Massachusetts General Hospital, Boston

07960

Morristown Medical Center, Morristown

07450

The Valley Hospital, Ridgewood

Unknown

Policlinico Di San Donato Milanese, Milanesi

"Ospedale F. Miulli", Bari

All Listed Sponsors
lead

Biosense Webster, Inc.

INDUSTRY

NCT03683030 - Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation | Biotech Hunter | Biotech Hunter