NCT05856799

Danish Randomized Trial on Leadless vs Transvenous Pacing

Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.

Conditions

• AV Block

Interventions

Type	Name	Description
DEVICE	Leadless Micra AV Transcatheter Pacing System	Patients are implanted with a leadless Micra AV TPS
DEVICE	Transvenous Azure XT DR dual chamber pacemaker	Patients are implanted with a transvenous Azure XT DR pacemaker

Timeline

• Start date: 2023-08-25
• Primary completion: 2025-11-01
• Completion: 2026-06-01
• First posted: 2023-05-12
• Last updated: 2025-04-01

Locations

2 sites across 1 country: Denmark