ong Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx study)

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002960
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Patients who diveloped drug-refractory atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
2. Age: 18-80 years
3. Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
4. Estimated percentage of atrial pacing >40% under sinus rhythm (LR=60bpm, close hysteresis and rest rate)
5. Estimated percentage of ventricular pacing >40% under sinus rhythm (LR=40bpm, DDD pacing, close hysteresis and rest rate)
6. Patients who are willing to sign the informed consent.
7. Patients who are willing to receive the implantation and post-operative follow-up.

Exclusion Criteria

1. Persistent or permanent AF
2. Severe hepatic and renal insufficiency (AST or ALT = three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
3. Thyroid gland dysfunction
4. Pregnancy
5. Malignant tumor
6. Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
7. Life expectancy < 12 months
8. Patients unable or unwilling to cooperate in the study procedures.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate of AF/AFL/AT in both groups

Secondary Outcome Measures

Name	Time	Method
eft ventricular ejection fraction;Left atrial diameter;Stroke