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)

C

China Cardiometabolic Registries

Status

Unknown

Conditions

Persistent Atrial Fibrillation

Treatments

Device: Radiofrequency Energy(Contact Force)
Device: Cryoballoon

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT03053570
Cryo Vs CF in PerAF

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Cryoballoon
Experimental group
Treatment:
Device: Radiofrequency Energy(Contact Force)
Device: Cryoballoon
Radiofrequency Energy(Contact Force)
Experimental group
Treatment:
Device: Radiofrequency Energy(Contact Force)
Device: Cryoballoon

Trial contacts and locations

0

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Central trial contact

Baopeng Tang, PhD

Data sourced from clinicaltrials.gov

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