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NCT Number: NCT03401593

Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

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.

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Key information

Conditions

Permanent Pacemaker Implantation Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location contact

Boyoung Joung, MD, Ph.D

CONTACT

[email protected]

82-2-2228-8460

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam with fentanyl

Drug

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.

Primary outcomes

  1. Recurrence rate of AF/AFL/AT in both groups

    Time frame: 1 year after randomization

    recurrence of AF/AFL/AT evaluated using device interrogation

  2. 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

  1. Left ventricular ejection fraction

    Time frame: 1 year after randomization

    cardiac function evaluated using echocardiography

  2. Left atrial diameter

    Time frame: 1 year after randomization

    cardiac function evaluated using echocardiography

  3. Stroke

    Time frame: at least 1 year after randomization

    ischemic and hemorrhagic stroke

  4. Stroke

    Time frame: 6-month follow up to 5 years

    ischemic and hemorrhagic stroke

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2018
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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