Atrial FibrillationNCT02392338
Hybrid Procedure in Patients With Persistent Atrial Fibrillation
A study testing Hybrid procedure in people with Atrial Fibrillation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Hybrid procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Long-lasting persistent atrial fibrillation
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
- over 18 years
Who cannot join
- Valvular heart disease of more than moderate degree
- Unresponsive ischemic cardiomyopathy
- Follow-up of over 1 year was not possible
- Warfarin was unable to be used
- Refusal of informed consent
- Left atrial thrombus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.
Read the detailed description
Atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. In Korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years.
Totally thoracoscopic ablation has been adopted and performed successfully on February 2012 at Samsung Medical Center for the first time in Korea. More than 120 operations have been performed up to date.
In Korea, treatment for atrial fibrillation is still dependent on percutaneous RFCA, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. The investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. Also, thoracoscopic ablation and RFCA are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported.
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour Holter monitoring of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.
- Conditions
- Atrial Fibrillation
- Being tested
- Hybrid procedure
- Keywords
- Atrial fibrillation, Ablation, Hybrid
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid procedureProcedure or surgery
Also called Postprocedural electrophysiological study
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic ablation group | No intervention | Patients who will undergo thoracoscopic ablation only |
| Hybrid procedure | Active comparator | Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation) Receives: Procedure: Hybrid procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac related death
medical records review
Measured: one year
Secondary outcomes (4)
Stroke
medical records review at 3, 6 and 12 months follow up
Measured: postoperative one year
Bleeding
medical records review at 3, 6 and 12 months follow up
Measured: postoperative one year
Embolism
medical records review at 3, 6 and 12 months follow up
Measured: postoperative one year
Recurred atrial arrhythmia
medical records review at 3, 6 and 12 months follow up
Measured: postoperative one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Keun On, Samsung Medical Center
- Investigators
- Young Keun On, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392338
- Sponsor's protocol ID
- 2012-10-090
- Status last verified
- Feb 2017
- First submitted
- 10 Nov 2014
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
PubMed 22742400Choi MS, On YK, Jeong DS, Park KM, Park SJ, Kim JS, Carriere KC. Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation. Am J Cardiol. 2020 Apr 1;125(7):1054-1062. doi: 10.1016/j.amjcard.2019.12.046. Epub 2020 Jan 8.
PubMed 31948665
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02392338
- Acronym / sponsor ID
- 2012-10-090
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Ablation, Hybrid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Mar 2015 (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.
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.
Detailed description
Atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. In Korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years.
Totally thoracoscopic ablation has been adopted and performed successfully on February 2012 at Samsung Medical Center for the first time in Korea. More than 120 operations have been performed up to date.
In Korea, treatment for atrial fibrillation is still dependent on percutaneous RFCA, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. The investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. Also, thoracoscopic ablation and RFCA are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported.
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour Holter monitoring of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic ablation group | No intervention | –Patients who will undergo thoracoscopic ablation only |
| Hybrid procedure | Active comparator | Procedure: Hybrid procedurePatients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Long-lasting persistent atrial fibrillation
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
- over 18 years
Key exclusion criteria (6 listed)
- Valvular heart disease of more than moderate degree
- Unresponsive ischemic cardiomyopathy
- Follow-up of over 1 year was not possible
- Warfarin was unable to be used
- Refusal of informed consent
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 |
|---|---|---|
| Hybrid procedureAlso: Postprocedural electrophysiological studyEletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium | Procedure or surgery | Hybrid procedure |
Primary outcome
Cardiac related death
Time frame: one year
medical records review
4 secondary outcomes
Stroke
Time frame: postoperative one year
Bleeding
Time frame: postoperative one year
Embolism
Time frame: postoperative one year
Recurred atrial arrhythmia
Time frame: postoperative one year
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 3 Feb 2017.
- Results publication: PubMed 22742400Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
- Derived from this study: PubMed 31948665Choi MS, On YK, Jeong DS, Park KM, Park SJ, Kim JS, Carriere KC. Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation. Am J Cardiol. 2020 Apr 1;125(7):1054-1062. doi: 10.1016/j.amjcard.2019.12.046. Epub 2020 Jan 8.
- 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.
Young Keun On, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid procedure in people with Atrial Fibrillation, run by Samsung Medical Center 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 3 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: finished, as of the sponsor's last update on 3 Feb 2017. 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. 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?
Cardiac related death (time frame: one year). 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 NCT02392338, which also lists 2 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 3 Feb 2017.