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

This study is currently recruiting participants.

Verified March 2013 by Princess Margaret Hospital, Hong Kong

Sponsor:

Information provided by (Responsible Party):

Ngai Yin Chan, Princess Margaret Hospital, Hong Kong

ClinicalTrials.gov Identifier:

NCT01584154

First received: April 21, 2012

Last updated: March 24, 2013

Last verified: March 2013

History of Changes

Purpose

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	Intervention	Phase
Supraventricular Tachycardia Atrioventricular Nodal Reentrant Tachycardia	Procedure: cryoablation Procedure: radiofrequency ablation	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment

Further study details as provided by Princess Margaret Hospital, Hong Kong:

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 [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Treatment success rate at 12 months [ Time Frame: 12 months after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	520
Study Start Date:	March 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584154

Contacts

Contact: Ngai-Yin Chan, MBBS

852 29903725 ext 3725

ngaiyinchan@yahoo.com.hk

Locations

China, Guangdong
Princess Margaret Hospital	Recruiting
Hong Kong, Guangdong, China
Contact: Ngai-Yin Chan, MBBS 852 29903725 ext 3725 ngaiyinchan@yahoo.com.hk
Principal Investigator: Ngai-Yin Chan, MBBS

Sponsors and Collaborators

Princess Margaret Hospital, Hong Kong

Investigators

Principal Investigator:

Ngai-Yin Chan, MBBS

Princess Margaret Hospital, Canada

More Information

Publications:

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 Mar 9. [Epub ahead of print]

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, 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. Epub 2009 May 17.

Responsible Party:	Ngai Yin Chan, Associate Consultant, Princess Margaret Hospital, Hong Kong
ClinicalTrials.gov Identifier:	NCT01584154 History of Changes
Other Study ID Numbers:	1101
Study First Received:	April 21, 2012
Last Updated:	March 24, 2013
Health Authority:	Hong Kong: Department of Health

Additional relevant MeSH terms:

Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Tachycardia, Supraventricular
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Reciprocating

ClinicalTrials.gov processed this record on May 21, 2013

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