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Long-term follow-up of atrial fibrillation in people with pacemakers

Studies whether treatment affects recurrence of irregular heart rhythms after pacemaker implantation.

Plain-language title generated from the registry record
Registry title: Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Key facts

Where
Seoul, South KoreaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 19 and 80 years old?

Source: NCT03401593, who can take part

Where in South Korea

  • Division of Cardiology, Yonsei University Health System, Yonsei University College of MedicineSeoul, South KoreaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Yonsei University
Trial code
NCT03401593
Record updated
29 August 2019
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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); Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min); Persistent or permanent AF; Thyroid gland dysfunction; Pregnancy; Life expectancy < 12 months; Patients unable or unwilling to cooperate in the study procedures.

ClinicalTrials.gov NCT03401593