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

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03044951
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 12.2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Efficacy endpoint (time to first documented clinical recurrence after blanking period) [one year]

   the time to first documented clinical recurrence after blanking period (month)

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

   Any procedure-related complications

Secondary Outcome Measures

1. Procedure time (min) [one year]

   skin to skin

2. Left atrial time (min) [one year]

3. X-ray time (min) [one year]

4. time to first time cardiovascular hospitalization (month) [one year]

5. QoL changes at 12 months (Units on a Scale) [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

• Ruijin Hospital

Investigators

• Principal Investigator: Li-Qun Wu, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qi Jin, Clinical Professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT03044951
• Other Study ID Numbers: DLY201604
• First Posted: Feb 7, 2017
• Last Update Posted: Feb 7, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qi Jin, Clinical Professor, Ruijin Hospital: atrial fibrillation; cryoablation; irrigated radiofrequency ablation; pulmonary vein isolation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Feb 7, 2017