Supraventricular TachycardiaPhase 4CRYOABLATENCT01584154
Comparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia
A Phase 4 study testing cryoablation and radiofrequency ablation in people with Supraventricular Tachycardia and Atrioventricular Nodal Reentrant Tachycardia, run by Princess Margaret Hospital, Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia
- What is being tested?
- cryoablation and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are referred for catheter ablation of supraventricular tachycardia and diagnosis of AVNRT is made by cardiac electrophysiology study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Princess Margaret Hospital
Hong Kong, Guangdong
Ngai-Yin Chan, MBBS, 852 29903725 ext. 3725, ngaiyinchan@yahoo.com.hk
Ngai-Yin Chan, MBBS
About this study
Official title: 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.
- Being tested
- cryoablation, radiofrequency ablation
- Medical subject headings
- Tachycardia, Supraventricular, Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablationProcedure or surgery
cryoablation with an 8mm-tip catheter
radiofrequency ablationProcedure or surgery
radiofrequency ablation with a 4mm-tip catheter
| Study group | Role | What they receive |
|---|---|---|
| cryoablation | Experimental | Not described Receives: Procedure: cryoablation |
| radiofrequency ablation | Active comparator | radiofrequency ablation with a 4mm-tip catheter Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after treatment
Secondary outcomes (1)
Treatment success rate at 12 months
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Margaret Hospital, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ngai Yin Chan, Princess Margaret Hospital, Hong Kong
- Investigators
- Ngai-Yin Chan, MBBS, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584154
- Sponsor's protocol ID
- 1101
- Acronym
- CRYOABLATE
- Status last verified
- Sep 2015
- First submitted
- 21 Apr 2012
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22403042Chan 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.
PubMed 20727096Chan 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.
PubMed 19451097
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment
- ClinicalTrials.gov ID
- NCT01584154
- Acronym / sponsor ID
- CRYOABLATE / 1101
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Princess Margaret Hospital, Hong KongOther government
- Study start
- Mar 2012
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryoablation | Experimental | Procedure: cryoablation |
| radiofrequency ablation | Active comparator | Procedure: radiofrequency ablationradiofrequency ablation with a 4mm-tip catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are referred for catheter ablation of supraventricular tachycardia and diagnosis of AVNRT is made by cardiac electrophysiology study
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryoablationcryoablation with an 8mm-tip catheter | Procedure or surgery | cryoablation |
| radiofrequency ablationradiofrequency ablation with a 4mm-tip catheter | Procedure or surgery | radiofrequency ablation |
Primary outcome
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
1 secondary outcome
Treatment success rate at 12 months
Time frame: 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Background: PubMed 22403042Chan 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.
- Background: PubMed 20727096Chan 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.
- Background: PubMed 19451097Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ngai-Yin Chan, MBBS principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cryoablation and radiofrequency ablation in people with Supraventricular Tachycardia and Atrioventricular Nodal Reentrant Tachycardia, run by Princess Margaret Hospital, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ngai-Yin Chan, MBBS (852 29903725 ext. 3725, ngaiyinchan@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01584154, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.