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Not yet recruiting NCT03401593

Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

No phase Interventional Permanent Pacemaker Implantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: midazolam with fentanyl.
Who it may be relevant to
Registry conditions: Permanent Pacemaker Implantation. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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 vei

Primary outcome measures

  • Recurrence rate of AF/AFL/AT in both groups [Time frame: 1 year after randomization]
  • Recurrence rate of AF/AFL/AT in both groups [Time frame: 6-month follow up to 5 years]
Secondary outcome measures (4)
  • Left ventricular ejection fraction [Time frame: 1 year after randomization]
  • Left atrial diameter [Time frame: 1 year after randomization]
  • Stroke [Time frame: at least 1 year after randomization]
  • Stroke [Time frame: 6-month follow up to 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Division of Cardiology, Yonsei University Health System, Yonsei University College of Medi — Seoul

Identifiers

NCT: NCT03401593 · 4-2017-1028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗