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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cryoballoon ablation
radiofrequency ablation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, cryoablation, irrigated radiofrequency ablation, pulmonary vein isolation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cryoballoon ablation

radiofrequency ablation

Arm Description

patients who accept cryoballoon ablation

patients who accept radiofrequency ablation

Outcomes

Primary Outcome Measures

Efficacy endpoint (time to first documented clinical recurrence after blanking period)
the time to first documented clinical recurrence after blanking period (month)
Safety endpoint (Any procedure-related complications)
Any procedure-related complications

Secondary Outcome Measures

Procedure time (min)
skin to skin
Left atrial time (min)
X-ray time (min)
time to first time cardiovascular hospitalization (month)
QoL changes at 12 months (Units on a Scale)

Full Information

First Posted
January 30, 2017
Last Updated
February 6, 2017
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03044951
Brief Title
Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）
Acronym
CRYO-AF
Official Title
Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, cryoablation, irrigated radiofrequency ablation, pulmonary vein isolation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cryoballoon ablation
Arm Type
Experimental
Arm Description
patients who accept cryoballoon ablation
Arm Title
radiofrequency ablation
Arm Type
Active Comparator
Arm Description
patients who accept radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
cryoballoon ablation
Intervention Description
cryoballoon ablation：pulmonary vein isolation by cryoballoon
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
radiofrequency ablation: pulmonary vein isolation by radiofrequency energy
Primary Outcome Measure Information:
Title
Efficacy endpoint (time to first documented clinical recurrence after blanking period)
Description
the time to first documented clinical recurrence after blanking period (month)
Time Frame
one year
Title
Safety endpoint (Any procedure-related complications)
Description
Any procedure-related complications
Time Frame
one year
Secondary Outcome Measure Information:
Title
Procedure time (min)
Description
skin to skin
Time Frame
one year
Title
Left atrial time (min)
Time Frame
one year
Title
X-ray time (min)
Time Frame
one year
Title
time to first time cardiovascular hospitalization (month)
Time Frame
one year
Title
QoL changes at 12 months (Units on a Scale)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Jin
Email
jinqi127@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Qun Wu
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Qun Wu
Email
wuliqun89@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tian-You Ling
Email
lty0919@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27042964
Citation
Kuck KH, Brugada J, Furnkranz 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 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
Results Reference
result
PubMed Identifier
24446022
Citation
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 Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):69-75. doi: 10.1161/CIRCEP.113.000586. Epub 2014 Jan 19.
Results Reference
result

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

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