NCT01584154

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

5.5 years

First QC Date

April 21, 2012

Last Update Submit

September 3, 2015

Conditions

Supraventricular TachycardiaAtrioventricular Nodal Reentrant Tachycardia

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months after treatment

Secondary Outcomes (1)

  • Treatment success rate at 12 months

    12 months after treatment

Study Arms (2)

cryoablation

EXPERIMENTAL
Procedure: cryoablation

radiofrequency ablation

ACTIVE COMPARATOR

radiofrequency ablation with a 4mm-tip catheter

Procedure: radiofrequency ablation

Interventions

cryoablationPROCEDURE

cryoablation with an 8mm-tip catheter

cryoablation
radiofrequency ablationPROCEDURE

radiofrequency ablation with a 4mm-tip catheter

radiofrequency ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are referred for catheter ablation of supraventricular tachycardia and diagnosis of AVNRT is made by cardiac electrophysiology study

You may not qualify if:

  • Patients who aged less than 18 or over 80.
  • Patients who are pregnant.
  • Patients who cannot give informed consent.
  • Patients who are judged to have severe mental impairment and cannot report symptoms of palpitation during follow-up.
  • Patients who had previous AVNRT ablation before.
  • Patients who have comorbid congenital heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Hong Kong, Guangdong, China

RECRUITING

Related Publications (3)

  • Chan NY, Mok NS, Choy CC, Lau CL, Chu PS, Yuen HC, Lau ST. Treatment of atrioventricular nodal re-entrant tachycardia by cryoablation with an 8-mm-tip catheter versus radiofrequency ablation. J Interv Card Electrophysiol. 2012 Sep;34(3):295-301. doi: 10.1007/s10840-012-9670-9. Epub 2012 Mar 9.

    PMID: 22403042BACKGROUND

  • Chan NY, Choy CC, Lau CL, Lo YK, Chu PS, Yuen HC, Choi YC, Lau ST. Cryoablation versus radiofrequency ablation for atrioventricular nodal reentrant tachycardia: patient pain perception and operator stress. Pacing Clin Electrophysiol. 2011 Jan;34(1):2-7. doi: 10.1111/j.1540-8159.2010.02858.x. Epub 2010 Aug 18.

    PMID: 20727096BACKGROUND

  • Chan NY, Mok NS, Lau CL, Lo YK, Choy CC, Lau ST, Choi YC. Treatment of atrioventricular nodal re-entrant tachycardia by cryoablation with a 6 mm-tip catheter vs. radiofrequency ablation. Europace. 2009 Aug;11(8):1065-70. doi: 10.1093/europace/eup121. Epub 2009 May 17.

    PMID: 19451097BACKGROUND

MeSH Terms

Conditions

Tachycardia, SupraventricularTachycardia, Atrioventricular Nodal Reentry

Interventions

CryosurgeryRadiofrequency Ablation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsTachycardia, Reciprocating

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeRadiofrequency TherapyTherapeutics

Study Officials

  • Ngai-Yin Chan, MBBS

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ngai-Yin Chan, MBBS

CONTACT

852 29903725ngaiyinchan@yahoo.com.hk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

April 21, 2012

First Posted

April 24, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

CN(1)