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

April 21, 2012
March 24, 2013
March 2012
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01584154 on ClinicalTrials.gov Archive Site
Treatment success rate at 12 months [ Time Frame: 12 months after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Supraventricular Tachycardia
  • Atrioventricular Nodal Reentrant Tachycardia
  • Procedure: cryoablation
    cryoablation with an 8mm-tip catheter
  • Procedure: radiofrequency ablation
    radiofrequency ablation with a 4mm-tip catheter
  • Experimental: cryoablation
    Intervention: Procedure: cryoablation
  • Active Comparator: radiofrequency ablation
    radiofrequency ablation with a 4mm-tip catheter
    Intervention: Procedure: radiofrequency ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
520
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Ngai-Yin Chan, MBBS 852 29903725 ext 3725 ngaiyinchan@yahoo.com.hk
China
 
NCT01584154
1101
No
Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Not Provided
Principal Investigator: Ngai-Yin Chan, MBBS Princess Margaret Hospital, Canada
Princess Margaret Hospital, Hong Kong
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP