NCT03401593Not yet recruiting
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx Study)
Source: ClinicalTrials.gov · Last updated 29 Aug 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 27 Dec 2017
- Start date
- 1 Oct 2019
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Yonsei University
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT03401593
What you commit to
- Study type: Interventional
- Planned participants: 135
- From 1 Oct 2019 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \> 3.5 mg/dl or Ccr \< 30ml/min)
Other
- Persistent or permanent AF
- Thyroid gland dysfunction
- Pregnancy
- Life expectancy \< 12 months
- Patients unable or unwilling to cooperate in the study procedures.
Who the study is looking for
- 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.
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.