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)

February 12, 2017 updated by: China Cardiometabolic Registries

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Baopeng Tang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoballoon
Device: Cryoballoon
use Cryoballoon to isolation the Pulmonary Vein
Device: Radiofrequency Energy(Contact Force)
use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein
Experimental: Radiofrequency Energy(Contact Force)
Device: Cryoballoon
use Cryoballoon to isolation the Pulmonary Vein
Device: Radiofrequency Energy(Contact Force)
use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with successful Pulmonary Vein Isolation
Time Frame: in one year
in one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Cardiometabolic Registries

Investigators

  • Study Chair: Baopeng Tang, First Affiliated Hospital of Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 12, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 12, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cryo Vs CF in PerAF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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