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

Yonsei University1 site in 1 country135 target enrollmentOctober 2019

ConditionsPermanent Pacemaker Implantation

Interventionsmidazolam with fentanyl

Drugsmidazolam with fentanyl

Overview

Phase: Not Applicable
Intervention: midazolam with fentanyl
Conditions: Permanent Pacemaker Implantation
Sponsor: Yonsei University
Enrollment: 135
Locations: 1
Primary Endpoint: Recurrence rate of AF/AFL/AT in both groups
Status: Not yet recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

October 2019

End Date

June 2028

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility 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.