Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorYonsei University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

135 Participants
are divided into 2 treatment groups
Group A: ablationActive comparator 1 intervention
Group B: non-ablationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recurrence rate of AF/AFL/AT in both groups

recurrence of AF/AFL/AT evaluated using device interrogation

Time frame
1 year after randomization
2

Recurrence rate of AF/AFL/AT in both groups

recurrence of AF/AFL/AT evaluated using device interrogation

Time frame
6-month follow up to 5 years

Secondary outcomes

1

Left ventricular ejection fraction

cardiac function evaluated using echocardiography

Time frame
1 year after randomization
2

Left atrial diameter

cardiac function evaluated using echocardiography

Time frame
1 year after randomization
3

Stroke

ischemic and hemorrhagic stroke

Time frame
at least 1 year after randomization
4

Stroke

ischemic and hemorrhagic stroke

Time frame
6-month follow up to 5 years

Other outcomes

Sponsors and contacts

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