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

Atrial Fibrillation Clinical Trial

— CRYO-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03044951
• Other study ID #: DLY201604
• Status: Recruiting
• Phase: N/A
• First received: January 30, 2017
• Last updated: February 6, 2017
• Start date: November 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2017
• Source: Ruijin Hospital
• Contact: Qi Jin
• Email: jinqi127[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• cryoballoon ablation
cryoballoon ablation:pulmonary vein isolation by cryoballoon
• radiofrequency ablation
radiofrequency ablation: pulmonary vein isolation by radiofrequency energy

Locations

Country	Name	City	State
China	Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Andrade JG, Khairy P, Macle L, Packer DL, Lehmann JW, Holcomb RG, Ruskin JN, Dubuc M. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial — View Citation

Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators.. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy endpoint (time to first documented clinical recurrence after blanking period)	the time to first documented clinical recurrence after blanking period (month)	one year
Primary	Safety endpoint (Any procedure-related complications)	Any procedure-related complications	one year
Secondary	Procedure time (min)	skin to skin	one year
Secondary	Left atrial time (min)		one year
Secondary	X-ray time (min)		one year
Secondary	time to first time cardiovascular hospitalization (month)		one year
Secondary	QoL changes at 12 months (Units on a Scale)		one year