Atrial FibrillationNCT02216903
Respiratory Motion Related Ablation Gap and Clinical Outcome After Catheter Ablation for Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
This is the evaluation which is associated with apnea symptom, one of the recurrence factors, after AF ablation to patients who diagnosed AF. This is the evaluation which is associated with excessive respiration exercise during AF ablation to patients who diagnosed AF. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 510 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Dec 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei Cardiovascular hospital, Yonsei university health system, Seoul, Korea.
Who may be able to join
- age 20~80
- Left atrium size <55mm
Who cannot join
- Permeant AF which is uncontrolled by cardioverting
- Valvular AF (mitral stenosis> grade 2, mitral valvuloplasty)
- Structural heart disease which is necessary operation to be healed.
- The patients who had history of ablation or maze operation
- The patients who have abnormal respiration by spinal or chest modification.
- accompany Severe disease in present
- Under age <20
Trial locations and contacts
1 site in 1 country.
About this study
This is the evaluation which is associated with apnea symptom, one of the recurrence factors, after AF ablation to patients who diagnosed AF.
This is the evaluation which is associated with excessive respiration exercise during AF ablation to patients who diagnosed AF.
This is the evaluation which is associated with excessive respiration exercise to make a gap during AF ablation to patients who diagnosed AF.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, sleep apnea
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Yonsei AF Cohort | Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical recurrence of atrial fibrillation (AF) after catheter ablation
We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Any ECG documentation of AF recurrence after 3 months was diagnosed as clinical recurrence.
Measured: after 90 days of catheter ablation and thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216903
- Sponsor's protocol ID
- 4-2014-0502
- Status last verified
- Feb 2018
- First submitted
- 13 Aug 2014
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Motion Related Ablation Gap and Clinical Outcome After Catheter Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02216903
- Acronym / sponsor ID
- 4-2014-0502
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Aug 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.
This is the evaluation which is associated with apnea symptom, one of the recurrence factors, after AF ablation to patients who diagnosed AF.
This is the evaluation which is associated with excessive respiration exercise during AF ablation to patients who diagnosed AF.
This is the evaluation which is associated with excessive respiration exercise to make a gap during AF ablation to patients who diagnosed AF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yonsei AF Cohort | – | –Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei Cardiovascular hospital, Yonsei university health system, Seoul, Korea.
Key inclusion criteria (2 listed)
- age 20~80
- Left atrium size <55mm
Key exclusion criteria (7 listed)
- Permeant AF which is uncontrolled by cardioverting
- Valvular AF (mitral stenosis> grade 2, mitral valvuloplasty)
- Structural heart disease which is necessary operation to be healed.
- The patients who had history of ablation or maze operation
- The patients who have abnormal respiration by spinal or chest modification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical recurrence of atrial fibrillation (AF) after catheter ablation
Time frame: after 90 days of catheter ablation and thereafter
We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Any ECG documentation of AF recurrence after 3 months was diagnosed as clinical recurrence.
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 27 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Yonsei University 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 7 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 27 Mar 2019. 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?
Clinical recurrence of atrial fibrillation (AF) after catheter ablation (time frame: after 90 days of catheter ablation and thereafter). 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 27 Mar 2019.