Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

Summary

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Conditions

• Atrial Fibrillation

Interventions

DEVICE

THERMOCOOL SMARTTOUCH® SF catheter

Radiofrequency Ablation

Sponsors & Collaborators

• Biosense Webster, Inc.

  lead INDUSTRY

Principal Investigators

• Andrea Natale, MD · Texas Cardiac Arrhythmia Research

• Francis Marchlinski, MD · University of Pennsylvania

• Bruce Koplan, MD · Brigham and Women's Hospital

• Walid Saliba, MD · The Cleveland Clinic

• Tristram Banhson, MD · Duke University

• Scott Pollak, MD · AdventHealth

• Hugh Calkins, MD · Johns Hopkins University

• Moussa Mansour, MD · Massachusetts General Hospital

• Douglas Packer, MD · Mayo Clinic Foundation

• Srinivas Dukkipati, MD · Icahn School of Medicine at Mount Sinai

• Larry Chinitz, MD · NYU Langone Medical Center

• Saumil Oza, MD · St. Vincent's

• Anshul Patel, MD · Emory University Saint Joseph's Hospital

• Robert Fishel, MD · JFK Medical Center

• William Maddox, MD · University of Alabama at Birmingham

• Alexander Mazur, MD · University of Iowa

• Daniel Melby, MD · Allina Health System

• Christopher Liu, MD · New York Presbyterian Hospital

• Kenneth Ellenbogen, MD · Virginia Commonwealth University

• Chad Brodt, MD · Stanford University

• Laurent Macle, MD · Montreal Heart

• Philip Gentlesk, MD · Sentara Heart Hospital

• James B Deville, MD · Baylor Research Institute

• Charles Athill, MD · San Diego Cardiac Center

• Craig Delaughter, MD · Texas Health Heart & Vascular

• Marwan Bahu, MD · Phoenix Cardiovascular Research Group

• Jose Osorio, MD · Affinity Cardiovascular Specialists (Alabama Cardiovascular Group)

• Marc Deyell, MD · St. Paul

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-01

Primary Completion

2019-06-05

Completion

2019-06-05

FDA Device

Yes