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)

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

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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