CRYOABLATE: Comparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia

• Sponsor: Princess Margaret Hospital, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01584154
• Collaborator: (none)
• Enrollment: 520
• Location: 1
• Arms: 2
• Duration (Months): 66
• Patients Per Site Per Month: 7.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia	Procedure: cryoablation; Procedure: radiofrequency ablation	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 520 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment
• Study Start Date: Mar 1, 2012
• Anticipated Primary Completion Date: Sep 1, 2017
• Anticipated Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cryoablation	Procedure: cryoablation; cryoablation with an 8mm-tip catheter
Active Comparator: radiofrequency ablation radiofrequency ablation with a 4mm-tip catheter	Procedure: radiofrequency ablation; radiofrequency ablation with a 4mm-tip catheter

Outcome Measures

Primary Outcome Measures

1. 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 [6 months after treatment]

Secondary Outcome Measures

1. Treatment success rate at 12 months [12 months after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are referred for catheter ablation of supraventricular tachycardia and diagnosis of AVNRT is made by cardiac electrophysiology study

Exclusion Criteria:

1. Patients who aged less than 18 or over 80.

2. Patients who are pregnant.

3. Patients who cannot give informed consent.

4. Patients who are judged to have severe mental impairment and cannot report symptoms of palpitation during follow-up.

5. Patients who had previous AVNRT ablation before.

6. Patients who have comorbid congenital heart disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Hospital	Hong Kong	Guangdong	China

Sponsors and Collaborators

• Princess Margaret Hospital, Hong Kong

Investigators

• Principal Investigator: Ngai-Yin Chan, MBBS, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Ngai Yin Chan, Consultant, Princess Margaret Hospital, Hong Kong
• ClinicalTrials.gov Identifier: NCT01584154
• Other Study ID Numbers: 1101
• First Posted: Apr 24, 2012
• Last Update Posted: Sep 4, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Tachycardia; Tachycardia, Supraventricular; Tachycardia, Atrioventricular Nodal Reentry; Tachycardia, Ventricular

Study Results

No Results Posted as of Sep 4, 2015