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

Last updated on July 2021

Recruitment

Recruitment Status: Active, not recruiting
Estimated Enrollment: 640

Summary

Conditions: Atrial Fibrillation
Type: Interventional
Phase: Phase 3
Design: Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 75 years
Gender: Both males and females

Description

The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multi-Electrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multi-Electrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF...

Tracking Information

NCT #: NCT03683030
Collaborators: Not Provided
Investigators: Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation Principal Investigator: Srinivas Dukkipati, MD Icahn School of Medicine at Mount Sinai Principal Investigator: Moussa Mansour, MD Massachusetts General Hospital Principal Investigator: J. Brian Deville, MD Baylor Research Institute Principal Investigator: Sandeep Goysl, MD Piedmont Hospital Principal Investigator: Arash Aryana, MD Mercy General Hospital Principal Investigator: Javier Roman-Gonzalez, MD Methodist Texsan Hospital Principal Investigator: Hugh Calkins, MD Johns Hopkins University Principal Investigator: Suneet Mittal, MD The Valley Hospital Principal Investigator: Bradley Knight, MD Northwestern Memorial Hospital Principal Investigator: Anshul Patel, MD Emory St Joseph's Hospital Principal Investigator: Sung Lee, MD Medstar Washington Hospital Center Principal Investigator: Douglas Packer, MD Mayo Clinic Principal Investigator: Michael Panutich, MD Hoag Memorial Hospital Presbyterian Principal Investigator: Robert Sangrigoli, MD Doylestown Hospital Principal Investigator: Sharon Shen, MD Vanderbilt Medical Center Principal Investigator: Dhanunjaya Lakkireddy, MD Kansas City Arrhythmia Research Principal Investigator: Haseeb Jafri, MD Kettering Medical Center Principal Investigator: Timothy Mahoney, MD Morristown Medical Center Principal Investigator: Stavros Mountantonakis, MD Lenox Hill Hospital Principal Investigator: Massimo Grimaldi, MD Miulli General Hospital Principal Investigator: James Freeman, MD Yale New Haven Hospital Principal Investigator: Andy Voigt, MD University of Pittsburgh Medical Center Principal Investigator: Venkata Sagi, MD Baptist Health Research Institute Principal Investigator: Anil Bhandari, MD University of Southern California Principal Investigator: Haroon Rashid, MD Inova Health Care Services Principal Investigator: Naushad Shaik, MD AdventHealth Orlando Principal Investigator: Alan Wimmer, MD Saint Luke's Hospital of Kansas City Principal Investigator: Frank Cuoco, MD Trident Medical Center Principal Investigator: Madhu Reddy, MD University of Kansas Medical Center Principal Investigator: Ryan Aleong, MD University of Colorado - Anschutz Medical Campus Principal Investigator: Andre Gauri, MD Spectrum Health System Principal Investigator: Raul Weiss, MD Ohio State University Principal Investigator: Craig Cameron, MD Oklahoma Heart Principal Investigator: MArwan Bahu, MD Phoenix Cardiovascular Research Group Principal Investigator: Darryl Wells, MD Swedish Medical Center Principal Investigator: Ethan Ellis, MD Med Center of the Rockies Principal Investigator: Carlo Pappone, MD Policlinico Di San Donato Milanese Principal Investigator: Abdi Rasekh, MD CHI Baylor St. Lukes Medical Center Principal Investigator: Liqun Wu, MD Ruijin Hospital Principal Investigator: Chenyang Jiang, MD Sir Run Run Shaw Hospital