Back to resultsComparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia (CRYOABLATE)
Primary Purpose
Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
cryoablation
radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Supraventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Patients who are referred for catheter ablation of supraventricular tachycardia and diagnosis of AVNRT is made by cardiac electrophysiology study
Exclusion Criteria:
- Patients who aged less than 18 or over 80.
- Patients who are pregnant.
- Patients who cannot give informed consent.
- Patients who are judged to have severe mental impairment and cannot report symptoms of palpitation during follow-up.
- Patients who had previous AVNRT ablation before.
- Patients who have comorbid congenital heart disease.
Sites / Locations
- Princess Margaret HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cryoablation
radiofrequency ablation
Arm Description
radiofrequency ablation with a 4mm-tip catheter
Outcomes
Primary Outcome Measures
treatment success rate, defined as proportion of treated patients with both atrioventricular block-free acute procedural success and mid-term success without recurrence at 6 months
Secondary Outcome Measures
Treatment success rate at 12 months
Full Information
NCT ID
NCT01584154
First Posted
April 21, 2012
Last Updated
September 3, 2015
Sponsor
Princess Margaret Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01584154
Brief Title
Comparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia
Acronym
CRYOABLATE
Official Title
CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Margaret Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and effectiveness of cryoablation and radiofrequency ablation in the treatment of the commonest kind of supraventricular tachycardia, namely atrioventricular nodal reentrant tachycardia. The study hypothesis is that cryoablation is non-inferior to radiofrequency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryoablation
Arm Type
Experimental
Arm Title
radiofrequency ablation
Arm Type
Active Comparator
Arm Description
radiofrequency ablation with a 4mm-tip catheter
Intervention Type
Procedure
Intervention Name(s)
cryoablation
Intervention Description
cryoablation with an 8mm-tip catheter
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
radiofrequency ablation with a 4mm-tip catheter
Primary Outcome Measure Information:
Title
treatment success rate, defined as proportion of treated patients with both atrioventricular block-free acute procedural success and mid-term success without recurrence at 6 months
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Treatment success rate at 12 months
Time Frame
12 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are referred for catheter ablation of supraventricular tachycardia and diagnosis of AVNRT is made by cardiac electrophysiology study
Exclusion Criteria:
Patients who aged less than 18 or over 80.
Patients who are pregnant.
Patients who cannot give informed consent.
Patients who are judged to have severe mental impairment and cannot report symptoms of palpitation during follow-up.
Patients who had previous AVNRT ablation before.
Patients who have comorbid congenital heart disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ngai-Yin Chan, MBBS
Phone
852 29903725
Ext
3725
Email
ngaiyinchan@yahoo.com.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngai-Yin Chan, MBBS
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Hong Kong
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ngai-Yin Chan, MBBS
Phone
852 29903725
Ext
3725
Email
ngaiyinchan@yahoo.com.hk
First Name & Middle Initial & Last Name & Degree
Ngai-Yin Chan, MBBS
12. IPD Sharing Statement
Citations:
PubMed Identifier
22403042
Citation
Chan NY, Mok NS, Choy CC, Lau CL, Chu PS, Yuen HC, Lau ST. Treatment of atrioventricular nodal re-entrant tachycardia by cryoablation with an 8-mm-tip catheter versus radiofrequency ablation. J Interv Card Electrophysiol. 2012 Sep;34(3):295-301. doi: 10.1007/s10840-012-9670-9. Epub 2012 Mar 9.
Results Reference
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PubMed Identifier
20727096
Citation
Chan NY, Choy CC, Lau CL, Lo YK, Chu PS, Yuen HC, Choi YC, Lau ST. Cryoablation versus radiofrequency ablation for atrioventricular nodal reentrant tachycardia: patient pain perception and operator stress. Pacing Clin Electrophysiol. 2011 Jan;34(1):2-7. doi: 10.1111/j.1540-8159.2010.02858.x. Epub 2010 Aug 18.
Results Reference
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PubMed Identifier
19451097
Citation
Chan NY, Mok NS, Lau CL, Lo YK, Choy CC, Lau ST, Choi YC. Treatment of atrioventricular nodal re-entrant tachycardia by cryoablation with a 6 mm-tip catheter vs. radiofrequency ablation. Europace. 2009 Aug;11(8):1065-70. doi: 10.1093/europace/eup121. Epub 2009 May 17.
Results Reference
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Learn more about this trial
Comparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia
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