Status:
NOT_YET_RECRUITING
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients
Lead Sponsor:
Yonsei University
Conditions:
Permanent Pacemaker Implantation
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pa...
Eligibility Criteria
Inclusion
- Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
- Age: 18-80 years
- Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
- Estimated percentage of atrial pacing \>40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
- Estimated percentage of ventricular pacing \>40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
- Patients who are willing to sign the informed consent.
- Patients who are willing to receive the implantation and post-operative follow-up.
Exclusion
- Persistent or permanent AF
- Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \> 3.5 mg/dl or Ccr \< 30ml/min)
- Thyroid gland dysfunction
- Pregnancy
- Malignant tumor
- Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
- Life expectancy \< 12 months
- Patients unable or unwilling to cooperate in the study procedures.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03401593
Start Date
October 1 2019
End Date
June 1 2028
Last Update
August 29 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, South Korea, 03722