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

NCT ID: NCT01584154

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Supraventricular Tachycardia Atrioventricular Nodal Reentrant Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cryoablation

Group Type EXPERIMENTAL

cryoablation

Intervention Type PROCEDURE

cryoablation with an 8mm-tip catheter

radiofrequency ablation

radiofrequency ablation with a 4mm-tip catheter

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

radiofrequency ablation with a 4mm-tip catheter

Interventions

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cryoablation

cryoablation with an 8mm-tip catheter

Intervention Type PROCEDURE

radiofrequency ablation

radiofrequency ablation with a 4mm-tip catheter

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ngai Yin Chan

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ngai-Yin Chan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Hong Kong, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ngai-Yin Chan, MBBS

Role: CONTACT

852 29903725 ext. 3725

Facility Contacts

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Ngai-Yin Chan, MBBS

Role: primary

852 29903725 ext. 3725

References

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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.

Reference Type BACKGROUND
PMID: 22403042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20727096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19451097 (View on PubMed)

Other Identifiers

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1101

Identifier Type: -

Identifier Source: org_study_id

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