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

Phase 4

• Conditions: Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia
• Interventions: Procedure: cryoablation; Procedure: radiofrequency ablation

• Registration Number: NCT01584154
• Lead Sponsor: Princess Margaret Hospital, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-21
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 520

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cryoablation	cryoablation	-
radiofrequency ablation	radiofrequency ablation	radiofrequency ablation with a 4mm-tip catheter

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Treatment success rate at 12 months	12 months after treatment

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇳 Hong Kong, Guangdong, China