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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03044951
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):
Qi Jin, Ruijin Hospital

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: cryoballoon ablation Procedure: radiofrequency ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
Study Start Date : November 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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)

  2. Safety endpoint (Any procedure-related complications) [ Time Frame: one year ]
    Any procedure-related complications

Secondary Outcome Measures :
  1. Procedure time (min) [ Time Frame: one year ]
    skin to skin

  2. Left atrial time (min) [ Time Frame: one year ]
  3. X-ray time (min) [ Time Frame: one year ]
  4. time to first time cardiovascular hospitalization (month) [ Time Frame: one year ]
  5. QoL changes at 12 months (Units on a Scale) [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03044951

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Contact: Qi Jin

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China, Shanghai
Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Li-Qun Wu   
Contact: Tian-You Ling   
Sponsors and Collaborators
Ruijin Hospital
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Principal Investigator: Li-Qun Wu Ruijin Hospital

Publications of Results:
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Responsible Party: Qi Jin, Clinical Professor, Ruijin Hospital Identifier: NCT03044951    
Other Study ID Numbers: DLY201604
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qi Jin, Ruijin Hospital:
atrial fibrillation
irrigated radiofrequency ablation
pulmonary vein isolation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes