Complication of Coronary Artery Bypass GraftNCT02035163
Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi
A study testing Two sites cryoablation in people with Complication of Coronary Artery Bypass Graft and Atrial Fibrillation, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
Atrial fibrillation after coronary artery bypass graft is a common complication. The investigators have thought that the mechanism of temporarily postoperative atrial fibrillation is closely related to the autonomic nervous system imbalance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Coronary Artery Bypass Graft, Atrial Fibrillation
- What is being tested?
- Two sites cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery graft bypass patient
- sinus rhythm
Who cannot join
- Patients using antiarrhythmic
- severe hypotension after surgery ( systolic blood pressure <90mmHg)
- history of atrial fibrillation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Seoul St Mary's Hospital
Seoul, Seo Cho Gu, 137-701
About this study
Atrial fibrillation after coronary artery bypass graft is a common complication.
The investigators have thought that the mechanism of temporarily postoperative atrial fibrillation is closely related to the autonomic nervous system imbalance.
In a last several years, cryoablation was substituted for atrial incision in many reports to simplify the maze procedure.
However, there has been no comparative study to delineate the feasibility of the use of cryoablation.
Read the detailed description
Modified maze procedures that use energy sources for the ablation of atrial fibrillation concomitant with cardiac surgery have been shown to improve outcomes in patients with atrial fibrillation. Cryoablation of atrial fibrillation recently has been shown to lead to outcomes that were at least equivalent to those reported for other energy modalities over both short- and medium-term follow-up times.
- Being tested
- Two sites cryoablation
- Keywords
- Atrial fibrillation, coronary artery bypass graft, cryoablation, ganglionic plexi
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two sites cryoablationProcedure or surgery
Two ganglionic plexi around atrium was performed with 90-second cryoablation.
| Study group | Role | What they receive |
|---|---|---|
| Two sites cryoablation group | Active comparator | Two ganglionic plexi around atrium was performed with 90-second cryoablation. Receives: Procedure: Two sites cryoablation |
| Control group | No intervention | No Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom of atrial fibrillation or other atrial arrhythmia
check the occurrence of atrial fibrillation through EKG monitoring And bradycardia(<40/min) or tachycardia(>110/min) does not occur
Measured: 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Coronary Artery Bypass GraftStudies 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
- 0 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
- Yong Seog Oh, Ph.D, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035163
- Sponsor's protocol ID
- APIP
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2014
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi
- ClinicalTrials.gov ID
- NCT02035163
- Acronym / sponsor ID
- APIP
- Keywords
- Atrial fibrillation, coronary artery bypass graft, cryoablation, ganglionic plexi
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 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.
Atrial fibrillation after coronary artery bypass graft is a common complication.
The investigators have thought that the mechanism of temporarily postoperative atrial fibrillation is closely related to the autonomic nervous system imbalance.
In a last several years, cryoablation was substituted for atrial incision in many reports to simplify the maze procedure.
However, there has been no comparative study to delineate the feasibility of the use of cryoablation.
Detailed description
Modified maze procedures that use energy sources for the ablation of atrial fibrillation concomitant with cardiac surgery have been shown to improve outcomes in patients with atrial fibrillation. Cryoablation of atrial fibrillation recently has been shown to lead to outcomes that were at least equivalent to those reported for other energy modalities over both short- and medium-term follow-up times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two sites cryoablation group | Active comparator | Procedure: Two sites cryoablationTwo ganglionic plexi around atrium was performed with 90-second cryoablation. |
| Control group | No intervention | –No Intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- coronary artery graft bypass patient
- sinus rhythm
Key exclusion criteria (3 listed)
- Patients using antiarrhythmic
- severe hypotension after surgery ( systolic blood pressure <90mmHg)
- history of atrial fibrillation
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 |
|---|---|---|
| Two sites cryoablationTwo ganglionic plexi around atrium was performed with 90-second cryoablation. | Procedure or surgery | Two sites cryoablation group |
Primary outcome
freedom of atrial fibrillation or other atrial arrhythmia
Time frame: 5 days after surgery
check the occurrence of atrial fibrillation through EKG monitoring And bradycardia(<40/min) or tachycardia(>110/min) does not occur
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- 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.
Yong Seog Oh, Ph.D study chair
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 Two sites cryoablation in people with Complication of Coronary Artery Bypass Graft and 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 2 inclusion and 3 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: withdrawn, 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. 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 was withdrawn before enrolling participants, so there are no results.
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 atrial fibrillation or other atrial arrhythmia (time frame: 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.