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

September 3, 2015 updated by: Ngai Yin Chan, Princess Margaret Hospital, Hong Kong

CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

520

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Hong Kong, Guangdong, China
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
        • Principal Investigator:
          • Ngai-Yin Chan, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment success rate at 12 months
Time Frame: 12 months after treatment
12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Margaret Hospital, Hong Kong

Investigators

  • Principal Investigator: Ngai-Yin Chan, MBBS, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

April 21, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (ESTIMATE)

April 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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