NCT03401593

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Permanent Pacemaker Implantation

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2018-01-17
• Last updated: 2019-08-29

Locations

1 site across 1 country: South Korea