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NCT03053570 Clinical Trial

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)

Persistent Atrial Fibrillation Clinical Trial

Official title:
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (PerAF)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03053570
Other study ID # Cryo Vs CF in PerAF
Secondary ID
Status Recruiting
Phase N/A
First received January 31, 2017
Last updated February 12, 2017
Start date March 1, 2017
Est. completion date December 31, 2018

Study information
Verified date February 2017
Source China Cardiometabolic Registries
Contact Baopeng Tang, PhD
Phone +86 13579881111
Email tangbaopeng1111@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Cryoballoon
use Cryoballoon to isolation the Pulmonary Vein
• Radiofrequency Energy(Contact Force)
use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein

Locations
Country Name City State
China First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang

Sponsors (1)
Lead Sponsor Collaborator
China Cardiometabolic Registries

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with successful Pulmonary Vein Isolation in one year
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