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

Summary

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.

Conditions

• Atrial Fibrillation

Interventions

DEVICE

Multi-Electrode RF Balloon Catheter

Multi-Electrode RF Balloon Catheter will be inserted

Sponsors & Collaborators

• Biosense Webster, Inc.

  lead INDUSTRY

Principal Investigators

• Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

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

• Moussa Mansour, MD · Massachusetts General Hospital

• J. Brian Deville, MD · Baylor Research Institute

• Sandeep Goysl, MD · Piedmont Hospital

• Arash Aryana, MD · Mercy General Hospital

• Javier Roman-Gonzalez, MD · Methodist Texsan Hospital

• Hugh Calkins, MD · Johns Hopkins University

• Suneet Mittal, MD · The Valley Hospital

• Bradley Knight, MD · Northwestern Memorial Hospital

• Anshul Patel, MD · Emory St Joseph's Hospital

• Sung Lee, MD · Medstar Health Research Institute

• Douglas Packer, MD · Mayo Clinic

• Michael Panutich, MD · Hoag Memorial Hospital Presbyterian

• Robert Sangrigoli, MD · Doylestown Hospital

• Sharon Shen, MD · Vanderbilt Medical Center

• Dhanunjaya Lakkireddy, MD · Kansas City Arrhythmia Research

• Haseeb Jafri, MD · Kettering Medical Center

• Timothy Mahoney, MD · Morristown Medical Center

• Stavros Mountantonakis, MD · Lenox Hill Hospital

• Massimo Grimaldi, MD · Miulli General Hospital

• James Freeman, MD · Yale New Haven Hospital

• Andy Voigt, MD · University of Pittsburgh Medical Center

• Venkata Sagi, MD · Baptist Health Research Institute

• Anil Bhandari, MD · University of Southern California

• Haroon Rashid, MD · Inova Health Care Services

• Naushad Shaik, MD · AdventHealth Orlando

• Alan Wimmer, MD · St. Luke's Hospital, Kansas City, Missouri

• Frank Cuoco, MD · Trident Medical Center

• Madhu Reddy, MD · University of Kansas Medical Center

• Ryan Aleong, MD · University of Colorado, Denver

• Andre Gauri, MD · Spectrum Health System

• Raul Weiss, MD · Ohio State University

• Craig Cameron, MD · Oklahoma Heart

• MArwan Bahu, MD · Phoenix Cardiovascular Research Group

• Darryl Wells, MD · Swedish Medical Center

• Ethan Ellis, MD · Med Center of the Rockies

• Carlo Pappone, MD · Policlinico Di San Donato Milanese

• Abdi Rasekh, MD · CHI Baylor St. Lukes Medical Center

• Liqun Wu, MD · Ruijin Hospital

• Chenyang Jiang, MD · Sir Run Run Shaw Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-22

Primary Completion

2022-02-18

Completion

2022-02-18

FDA Device

Yes

Countries

• United States
• China
• Italy

Study Locations