Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Not Applicable

Not yet recruiting

• Conditions: Permanent Pacemaker Implantation
• Interventions: Drug: midazolam with fentanyl

• Registration Number: NCT03401593
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-29
• Study Start: 2019-10
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

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

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ablation	midazolam with fentanyl	Patients in this group are treated with radio-frequency catheter ablation.

Primary Outcome Measures

Name	Time	Method
Recurrence rate of AF/AFL/AT in both groups	6-month follow up to 5 years	recurrence of AF/AFL/AT evaluated using device interrogation

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	1 year after randomization	cardiac function evaluated using echocardiography
Left atrial diameter	1 year after randomization	cardiac function evaluated using echocardiography
Stroke	6-month follow up to 5 years	ischemic and hemorrhagic stroke

Trial Locations

Locations (1)

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of