Paroxysmal Atrial FibrillationNCT02031705
Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation
A study testing cavotricuspid isthmus ablation in people with Paroxysmal Atrial Fibrillation, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus ablation on atrial fibrillation itself is unclear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- cavotricuspid isthmus ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Aug 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled ablation for paroxysmal atrial fibrillation
Who cannot join
- Typical atrial flutter
- History of artificial tricuspid valve surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation for Paroxysmal Atrial Fibrillation
It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus ablation on atrial fibrillation itself is unclear.
Read the detailed description
Researchers hypothesized that an organized activation pattern around the tricuspid annulus during atrial fibrillation indicated a mother reentrant circuit that could be terminated by a cavocaval isthmus ablation, thus preventing atrial fibrillation. The objectives of the present study were to evaluate the effectiveness of isthmus ablation in preventing atrial fibrillation and to identify predictors of its success.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- cavotricuspid isthmus ablation, control group
- Keywords
- Fibrillation, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cavotricuspid isthmus ablationProcedure or surgery
Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
control groupProcedure or surgery
Control group was performed no additional cavotricuspid isthmus ablation.
| Study group | Role | What they receive |
|---|---|---|
| cavotricuspid isthmus ablation | Active comparator | Isthmus ablation was performed in paroxysmal atrial fibrillation patients. Receives: Procedure: cavotricuspid isthmus ablation |
| control group | Placebo comparator | Control group was performed no additional cavotricuspid isthmus ablation. Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of AF and Af
1 month, 3 months and 12months after ablation follow up visit and Check the recurrence of atrial fibrillation through EKG,Holter, event recording
Measured: 1 year after catheter ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionJun 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Seog Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Seog Oh, Seoul St. Mary's Hospital
- Investigators
- SungHwan Kim, MD, Study director, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031705
- Sponsor's protocol ID
- CTI
- Status last verified
- Apr 2024
- First submitted
- 9 Sep 2013
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim SH, Oh YS, Choi Y, Hwang Y, Kim JY, Kim TS, Kim JH, Jang SW, Lee MY, Joung B, Choi KJ. Long-Term Efficacy of Prophylactic Cavotricuspid Isthmus Ablation during Atrial Fibrillation Ablation in Patients Without Typical Atrial Flutter: a Prospective, Multicentre, Randomized Trial. Korean Circ J. 2021 Jan;51(1):58-64. doi: 10.4070/kcj.2020.0174. Epub 2020 Sep 14.
PubMed 33150753
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation for Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02031705
- Acronym / sponsor ID
- CTI
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Fibrillation, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 9 Jan 2014 (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.
It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus ablation on atrial fibrillation itself is unclear.
Detailed description
Researchers hypothesized that an organized activation pattern around the tricuspid annulus during atrial fibrillation indicated a mother reentrant circuit that could be terminated by a cavocaval isthmus ablation, thus preventing atrial fibrillation. The objectives of the present study were to evaluate the effectiveness of isthmus ablation in preventing atrial fibrillation and to identify predictors of its success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cavotricuspid isthmus ablation | Active comparator | Procedure: cavotricuspid isthmus ablationIsthmus ablation was performed in paroxysmal atrial fibrillation patients. |
| control group | Placebo comparator | Procedure: control groupControl group was performed no additional cavotricuspid isthmus ablation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled ablation for paroxysmal atrial fibrillation
Key exclusion criteria (2 listed)
- Typical atrial flutter
- History of artificial tricuspid valve surgery
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 |
|---|---|---|
| cavotricuspid isthmus ablationIsthmus ablation was performed in paroxysmal atrial fibrillation patients. | Procedure or surgery | cavotricuspid isthmus ablation |
| control groupControl group was performed no additional cavotricuspid isthmus ablation. | Procedure or surgery | control group |
Primary outcome
Freedom of AF and Af
Time frame: 1 year after catheter ablation
1 month, 3 months and 12months after ablation follow up visit and Check the recurrence of atrial fibrillation through EKG,Holter, event recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 33150753Kim SH, Oh YS, Choi Y, Hwang Y, Kim JY, Kim TS, Kim JH, Jang SW, Lee MY, Joung B, Choi KJ. Long-Term Efficacy of Prophylactic Cavotricuspid Isthmus Ablation during Atrial Fibrillation Ablation in Patients Without Typical Atrial Flutter: a Prospective, Multicentre, Randomized Trial. Korean Circ J. 2021 Jan;51(1):58-64. doi: 10.4070/kcj.2020.0174. Epub 2020 Sep 14.
- Individual participant dataSharing planned: No
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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.
SungHwan Kim, MD study director
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cavotricuspid isthmus ablation in people with Paroxysmal Atrial Fibrillation, run by Yong Seog Oh at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 23 Apr 2024. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of AF and Af (time frame: 1 year after catheter ablation). 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 NCT02031705, which also lists 1 linked publication.
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 23 Apr 2024.