Back to resultsStudy Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)
Primary Purpose
Persistent Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cryoballoon
Radiofrequency Energy(Contact Force)
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Cryoballoon, Contact Force, Persistent Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.
Exclusion Criteria:
- Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.
Sites / Locations
- First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cryoballoon
Radiofrequency Energy(Contact Force)
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with successful Pulmonary Vein Isolation
Secondary Outcome Measures
Full Information
NCT ID
NCT03053570
First Posted
January 31, 2017
Last Updated
February 12, 2017
Sponsor
China Cardiometabolic Registries
1. Study Identification
Unique Protocol Identification Number
NCT03053570
Brief Title
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)
Official Title
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (PerAF)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Cardiometabolic Registries
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.
Detailed Description
The hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent AF and is associated with a better long term outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Cryoballoon, Contact Force, Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryoballoon
Arm Type
Experimental
Arm Title
Radiofrequency Energy(Contact Force)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cryoballoon
Intervention Description
use Cryoballoon to isolation the Pulmonary Vein
Intervention Type
Device
Intervention Name(s)
Radiofrequency Energy(Contact Force)
Intervention Description
use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein
Primary Outcome Measure Information:
Title
Number of participants with successful Pulmonary Vein Isolation
Time Frame
in 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:
persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.
Exclusion Criteria:
Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baopeng Tang, PhD
Phone
+86 13579881111
Email
tangbaopeng1111@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baopeng Tang
Organizational Affiliation
First Affiliated Hospital of Xinjiang Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baopeng Tang
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)
We'll reach out to this number within 24 hrs