Atrial Fibrillation, PersistentNCT04500184
Exercise-based Cardiac Rehabilitation After Thoracoscopic Ablation in Patients With Persisent Atrial Fibrillation
An observational study of Atrial Fibrillation, Persistent and Cardiac Rehabilitation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However, the postoperative rehabilitation is very important to prevent early recurrence of atrial arrhythmia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent, Cardiac Rehabilitation, Cardiopulmonary Fitness
- What is being tested?
- cardiac rehabilitation
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 31 May 2020
- Phase
- Observational
- 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
Study population: Patients who underwent thoracoscopic ablation were included. cardiac rehabilitation was performed according to the willingness of each patients.
Who may be able to join
- patients who underwent thoracoscopic ablation due to persisent atrial fibrillation
Who cannot join
- below 18 years
- over 80 years old
- malignancy
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Exercise-based Cardiac Rehabilitation Increase Physical Activity in Patients Who Undergoing Totally Thoracoscopic Ablation?
Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However, the postoperative rehabilitation is very important to prevent early recurrence of atrial arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac rehabilitation in patients after thoracoscopic ablation.
- Being tested
- cardiac rehabilitation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitationOther
rehabilitation performed by professional trainers
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | patients who underwent cardiac rehabilitation Receives: Other: cardiac rehabilitation | |
| Control group | patients who did not undergo cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
Atrial fibrillation recurrence after surgical treatment
Measured: every 6 months for 1 year
functional recovery
exercise capacity and international physical activity questionnaire
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jun 2017
- Primary completion30 May 2018
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Seop Jeong, Samsung Medical Center
- Investigators
- Dong Seop Jeong, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500184
- Sponsor's protocol ID
- samsungmc_rehab_TTA
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Exercise-based Cardiac Rehabilitation Increase Physical Activity in Patients Who Undergoing Totally Thoracoscopic Ablation?
- ClinicalTrials.gov ID
- NCT04500184
- Acronym / sponsor ID
- samsungmc_rehab_TTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 5 Aug 2020 (actual)
- 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.
Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However, the postoperative rehabilitation is very important to prevent early recurrence of atrial arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac rehabilitation in patients after thoracoscopic ablation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | – | Other: cardiac rehabilitationpatients who underwent cardiac rehabilitation |
| Control group | – | –patients who did not undergo cardiac rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent thoracoscopic ablation were included. cardiac rehabilitation was performed according to the willingness of each patients.
Key inclusion criteria (1 listed)
- patients who underwent thoracoscopic ablation due to persisent atrial fibrillation
Key exclusion criteria (4 listed)
- below 18 years
- over 80 years old
- malignancy
- pregnancy
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 |
|---|---|---|
| cardiac rehabilitationrehabilitation performed by professional trainers | Other | Exercise group |
Primary outcome
Recurrence of atrial fibrillation
Time frame: every 6 months for 1 year
Atrial fibrillation recurrence after surgical treatment
functional recovery
Time frame: 6 months after intervention
exercise capacity and international physical activity questionnaire
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 5 Aug 2020.
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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.
Dong Seop Jeong, 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?
An observational study of Atrial Fibrillation, Persistent and Cardiac Rehabilitation, 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 1 inclusion and 4 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 5 Aug 2020. 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?
Recurrence of atrial fibrillation (time frame: every 6 months for 1 year). The study lists 2 primary outcomes in all. 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 5 Aug 2020.