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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Princess Margaret Hospital, Hong Kong
Sponsor:
Information provided by (Responsible Party):
Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01584154
First received: April 21, 2012
Last updated: March 24, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment success rate at 12 months [ Time Frame: 12 months after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 520
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Ngai Yin Chan, Associate Consultant, Princess Margaret Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT01584154     History of Changes
Other Study ID Numbers: 1101
Study First Received: April 21, 2012
Last Updated: March 24, 2013
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Tachycardia, Reciprocating

ClinicalTrials.gov processed this record on November 25, 2014