Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF） (CRYO-AF)

February 6, 2017 updated by: Qi Jin, Ruijin Hospital

Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study

It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.

Study Type

Interventional

Enrollment (Anticipated)

600

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025

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:

  • ECG recording of atrial fibrillation
  • first time of ablation
  • refractory to at least one anti-arrhythmia drug
  • sign informed consent for participation in the study

Exclusion Criteria:

  • had ablation before
  • serious heart failure
  • left atrial diameter>55mm
  • Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
  • Stroke in 6 months before the ablation
  • Endocardial thrombosis

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 ablation
patients who accept cryoballoon ablation
Procedure: cryoballoon ablation
cryoballoon ablation：pulmonary vein isolation by cryoballoon
Active Comparator: radiofrequency ablation
patients who accept radiofrequency ablation
Procedure: radiofrequency ablation
radiofrequency ablation: pulmonary vein isolation by radiofrequency energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy endpoint (time to first documented clinical recurrence after blanking period)
Time Frame: one year
the time to first documented clinical recurrence after blanking period (month)
one year
Safety endpoint (Any procedure-related complications)
Time Frame: one year
Any procedure-related complications
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time (min)
Time Frame: one year
skin to skin
one year
Left atrial time (min)
Time Frame: one year
one year
X-ray time (min)
Time Frame: one year
one year
time to first time cardiovascular hospitalization (month)
Time Frame: one year
one year
QoL changes at 12 months (Units on a Scale)
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Li-Qun Wu, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2016

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLY201604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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