A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF

NAActive, not recruitingINTERVENTIONAL
Enrollment

237

Participants

Timeline

Start Date

December 7, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Drug Refractory Paroxysmal Atrial Fibrillation
Interventions
DEVICE

THERMOCOOL STSF Bi- Directional Navigation Catheter

THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.

DEVICE

TRUPULSE Generator

TRUPULSE Generator will be used to deliver PF/RF ablation.

Trial Locations (29)

10016

NYU Langone Health, New York

10467

Montefiore Medical Center, The Bronx

23507

Sentara Norfolk General Hospital, Norfolk

27157

Wake Forest Baptist Medical Center, Winston-Salem

29406

Trident Medical Center, North Charleston

31201

Georgia Arrhythmia Consultants and Research Institute, Macon

31404

Memorial Health University Medical Center, Savannah

32204

Ascension St. Vincent's, Jacksonville

33133

HCA Florida Mercy Hospital, Miami

33462

HCA Florida JFK Hospital, Atlantis

34239

Sarasota Memorial Hospital, Sarasota

35243

Grandview Medical Center, Birmingham

35294

University of Alabama at Birmingham, Birmingham

40205

Norton Heart Specialist, Louisville

40503

Baptist Health Lexington, Lexington

43210

Ohio State University, Columbus

43214

Ohio Health Research Institute, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

48197

Trinity Health Michigan Heart - Ann Arbor Campus, Ypsilanti

60153

Loyola University Medical Center, Maywood

60612

Rush University Medical Center, Chicago

66160

University of Kansas Medical Center, Kansas City

66211

The Kansas City Heart Rhythm Institute, Overland Park

75093

Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano, Plano

78201

Methodist Texsan, San Antonio

78705

Texas Cardiac Arrhythmia Research Foundation, Austin

90033

Keck School of Medicine of USC, Los Angeles

02114

Massachusetts General, Boston

08035

Cardiovascular Associates of the Delaware Valley, Haddon Heights

All Listed Sponsors
lead

Biosense Webster, Inc.

INDUSTRY

NCT06144632 - A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF | Biotech Hunter | Biotech Hunter