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

Princess Margaret Hospital, Hong Kong

Status and phase: Unknown; Phase 4

Conditions: Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia

Treatments: Procedure: cryoablation; Procedure: radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01584154

1101

Details and patient eligibility

About

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.

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 2 patient groups

cryoablation

Experimental group

Treatment:

Procedure: cryoablation

radiofrequency ablation

Active Comparator group

Description:

radiofrequency ablation with a 4mm-tip catheter

Treatment:

Procedure: radiofrequency ablation