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

Supraventricular Tachycardia Clinical Trial

— CRYOABLATE  

Official title:

CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01584154
• Other study ID #: 1101
• Status: Recruiting
• Phase: Phase 4
• First received: April 21, 2012
• Last updated: September 3, 2015
• Start date: March 2012
• Est. completion date: September 2017

Study information

• Verified date: September 2015
• Source: Princess Margaret Hospital, Hong Kong
• Contact: Ngai-Yin Chan, MBBS
• Phone: 852 29903725
• Email: ngaiyinchan[@]yahoo.com.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrioventricular Nodal Reentrant Tachycardia
• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry
• Tachycardia, Supraventricular

Intervention

Procedure:
• cryoablation
cryoablation with an 8mm-tip catheter
• radiofrequency ablation
radiofrequency ablation with a 4mm-tip catheter

Locations

Country	Name	City	State
China	Princess Margaret Hospital	Hong Kong	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Princess Margaret Hospital, Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Treatment success rate at 12 months		12 months after treatment	Yes