Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

• Status: Not yet recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

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 pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Fentanyl; Midazolam

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.