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Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

NCT04133168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2025-04-03

Study results available
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Summary

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Boston Scientific Cardiac Cryoablation System

The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx™ FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Kenneth Ellenbogen, MD · VCU Pauley Heart Center, Richmond, Virginia, USA

  • Arash Aryana, MD, PhD · Mercy General Hospital,Sacramento, CA , USA

  • Nassir Marrouche, MD · University of Utah School of Medicine. Slat Lake City, UT, USA

  • Ante Anić, MD · University Hospital, Split, Croatia

  • Suneet Mittal, MD,FACC,FHRS · Snyder AF Center, New York, NY, USA

  • Niraj Varma, MD,PhD,FRCP · Cleveland Clinic, Cleveland OH, USA

  • Wilber W Su, MD,FACC,FHRS · Banner- University Medical Group- Heart Center, Phoenix, AZ, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2022-11-10
Completion
2023-08-17
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04133168 on ClinicalTrials.gov