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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Ngai Yin Chan, Princess Margaret Hospital, Hong Kong.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01584154
First Posted: April 24, 2012
Last Update Posted: September 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
  Purpose
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.

Condition Intervention Phase
Supraventricular Tachycardia Atrioventricular Nodal Reentrant Tachycardia Procedure: cryoablation Procedure: radiofrequency ablation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment

Further study details as provided by Ngai Yin Chan, Princess Margaret Hospital, Hong Kong:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Treatment success rate at 12 months [ Time Frame: 12 months after treatment ]

Estimated Enrollment: 520
Study Start Date: March 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584154


Contacts
Contact: Ngai-Yin Chan, MBBS 852 29903725 ext 3725 ngaiyinchan@yahoo.com.hk

Locations
China, Guangdong
Princess Margaret Hospital Recruiting
Hong Kong, Guangdong, China
Contact: Ngai-Yin Chan, MBBS    852 29903725 ext 3725    ngaiyinchan@yahoo.com.hk   
Principal Investigator: Ngai-Yin Chan, MBBS         
Sponsors and Collaborators
Princess Margaret Hospital, Hong Kong
Investigators
Principal Investigator: Ngai-Yin Chan, MBBS Princess Margaret Hospital, Canada