NCT02216903

Brief 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. This is the evaluation which is associated with excessive respiration exercise to make a gap during AF ablation to patients who diagnosed AF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 27, 2019

Status Verified

February 1, 2018

Enrollment Period

3.3 years

First QC Date

August 13, 2014

Last Update Submit

March 26, 2019

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, sleep apnea

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 90 days of catheter ablation and thereafter

Study Arms (1)

Yonsei AF Cohort

Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei Cardiovascular hospital, Yonsei university health system, Seoul, Korea.

You may qualify if:

  • age 20\~80
  • Left atrium size \<55mm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Atrial FibrillationSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 27, 2019

Record last verified: 2018-02

Locations

KR(1)