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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
April 21, 2012
April 24, 2012
September 4, 2015
March 2012
September 2017   (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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
520
September 2017
September 2017   (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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01584154
1101
No
Not Provided
Not Provided
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
September 2015

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