Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Permanent Pacemaker Implantation

Intervention / Treatment
-----------------
* Drug: midazolam with fentanyl


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ablation<br>Patients in this group are treated with radio-frequency catheter ablation. | Drug: midazolam with fentanyl<br>* 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.<br>|
| No Intervention: non-ablation<br>Patients in this group are treated with rate control medications (e.g., beta blocker, calcium channel blocker, and digitalis) and anti-arrhythmic drugs. They also can be treated with DC cardio-version. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of AF/AFL/AT in both groups | recurrence of AF/AFL/AT evaluated using device interrogation | 1 year after randomization | 
| Recurrence rate of AF/AFL/AT in both groups | recurrence of AF/AFL/AT evaluated using device interrogation | 6-month follow up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | cardiac function evaluated using echocardiography | 1 year after randomization | 
| Left atrial diameter | cardiac function evaluated using echocardiography | 1 year after randomization | 
| Stroke | ischemic and hemorrhagic stroke | at least 1 year after randomization | 
| Stroke | ischemic and hemorrhagic stroke | 6-month follow up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, ablation, atrial fibrillation