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Clinical Trials in South Korea / NCT03401593
Starting soon Not applicable

Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

NCT03401593 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2019-10
Last updated
2019-08-29

Condition(s) studied

Permanent Pacemaker Implantation

Investigational drug(s) / intervention(s)

midazolam with fentanyl

midazolam with fentanyl: Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary veins. Successful ablation was defined by the elimination of all the pulmonary vein potentials along the antrum or inside the veins. If the AF was not terminated after elimination of all the pulmonary vein potentials, linear ablation and complex fragmented atrial electrogram ablation were performed.

Study 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

Sex
ALL
Min age
19 Years
Max age
80 Years
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.

Primary outcome measure(s)

  • Recurrence rate of AF/AFL/AT in both groups — 1 year after randomization
    recurrence of AF/AFL/AT evaluated using device interrogation
  • 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

Trial sites (1)

FacilityCityRegionStatus
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03401593 on ClinicalTrials.gov ↗ ← All trials in South Korea