Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)
Not Applicable
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Device: CryoballoonDevice: Radiofrequency Energy(Contact Force)
- Registration Number
- NCT03053570
- Lead Sponsor
- China Cardiometabolic Registries
- Brief Summary
The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.
- Detailed Description
The hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent AF and is associated with a better long term outcome.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.
Exclusion Criteria
- Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiofrequency Energy(Contact Force) Cryoballoon - Cryoballoon Cryoballoon - Cryoballoon Radiofrequency Energy(Contact Force) - Radiofrequency Energy(Contact Force) Radiofrequency Energy(Contact Force) -
- Primary Outcome Measures
Name Time Method Number of participants with successful Pulmonary Vein Isolation in one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China