NCT03401593Not yet recruitingNot Applicable
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx Study)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Yonsei University
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Recurrence rate of AF/AFL/AT in both groups
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ablation
Active Comparator
Patients in this group are treated with radio-frequency catheter ablation.
Intervention: midazolam with fentanyl (Drug)
Outcomes
Primary Outcomes
Recurrence rate of AF/AFL/AT in both groups
Time Frame: 6-month follow up to 5 years
recurrence of AF/AFL/AT evaluated using device interrogation
Secondary Outcomes
- Left ventricular ejection fraction(1 year after randomization)
- Left atrial diameter(1 year after randomization)
- Stroke(6-month follow up to 5 years)
Investigators
Study Sites (1)
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