Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Paroxysmal Atrial Fibrillation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: open label, prospective, single arm studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific's Cryoablation System. The Cryoablation System is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment o...
Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific's Cryoablation System. The Cryoablation System is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for twelve (12) months after the index procedure.
Tracking Information
- NCT #
- NCT04133168
- Collaborators
- Not Provided
- Investigators
- Study Chair: Kenneth Ellenbogen, MD VCU Pauley Heart Center, Richmond, Virginia, USA Principal Investigator: Arash Aryana, MD, PhD Mercy General Hospital,Sacramento, CA , USA Principal Investigator: Nassir Marrouche, MD University of Utah School of Medicine. Slat Lake City, UT, USA Principal Investigator: Ante Ani?, MD University Hospital, Split, Croatia Principal Investigator: Suneet Mittal, MD, FACC, FHRS Snyder AF Center, New York, NY, USA Principal Investigator: Niraj Varma, MD, PhD, FRCP Cleveland Clinic, Cleveland OH, USA Principal Investigator: Wilber W Su, MD, FACC, FHRS Banner- University Medical Group- Heart Center, Phoenix, AZ, USA
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