Clinical trial NCT03401593: Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients
Official title: Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Permanent Pacemaker Implantation
Keywords: ablation
atrial fibrillation
stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 135
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recurrence rate of AF/AFL/AT in both groups
timeFrame: 1 year after randomization
measure: Recurrence rate of AF/AFL/AT in both groups
timeFrame: 6-month follow up to 5 years
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 1 year after randomization
measure: Left atrial diameter
timeFrame: 1 year after randomization
measure: Stroke
timeFrame: at least 1 year after randomization
measure: Stroke
timeFrame: 6-month follow up to 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Study officials:
References: