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)

NCT ID: NCT03053570

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cryoballoon

Group Type EXPERIMENTAL

Cryoballoon

Intervention Type DEVICE

use Cryoballoon to isolation the Pulmonary Vein

Radiofrequency Energy(Contact Force)

Intervention Type DEVICE

use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein

Radiofrequency Energy(Contact Force)

Group Type EXPERIMENTAL

Cryoballoon

Intervention Type DEVICE

use Cryoballoon to isolation the Pulmonary Vein

Radiofrequency Energy(Contact Force)

Intervention Type DEVICE

use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein

Interventions

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Cryoballoon

use Cryoballoon to isolation the Pulmonary Vein

Intervention Type DEVICE

Radiofrequency Energy(Contact Force)

use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Cardiometabolic Registries

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Baopeng Tang

Role: STUDY_CHAIR

First Affiliated Hospital of Xinjiang Medical University

Locations

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First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Baopeng Tang, PhD

Role: CONTACT

+86 13579881111

Facility Contacts

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Baopeng Tang

Role: primary

Other Identifiers

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Cryo Vs CF in PerAF

Identifier Type: -

Identifier Source: org_study_id

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