The Leadless AV Versus DDD Pacing Study

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Aug 8, 2022

Keywords

ClinConnect Summary

The Leadless AV Versus DDD Pacing Study is a clinical trial that aims to compare two types of cardiac pacemakers in patients who have issues with heart rhythm, specifically atrioventricular (AV) block. One device being tested is the new Micra AV™ pacemaker, which is leadless and can monitor both the upper and lower chambers of the heart. The other is a conventional dual-chamber pacemaker that uses wires (or leads) to connect to the heart. Researchers want to find out if the Micra AV™ can help patients perform physical activities just as well as the traditional pacemaker.

To participate in this trial, patients must be at least 70 years old and need a pacemaker due to AV block. Those interested will be randomly assigned to receive either the Micra AV™ or the conventional pacemaker. Participants can expect to undergo the pacemaker implantation procedure and will be monitored to assess their physical exercise capacity. This study is currently recruiting participants, and it's important for potential candidates to understand the eligibility criteria and to provide informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients (≥70y) undergoing a de-novo pacemaker implantation due to intermittent or permanent AV block, qualifying for a conventional or leadless pacemaker
• • Written informed consent
• Exclusion Criteria:
• • Permanent atrial fibrillation or atrial standstill
• • Evidence of sinus node disease and need for right atrial pacing (not possible with Micra AV)
• • LVEF \<50% and permanent high-degree or total AVB (requiring CRT/His-Bundle/CSP pacing)
• • Preoperative E/A ratio \>1.5 in the echocardiography
• • Any co-existing ICD indications (no leadless ICD systems available)
• • Hemodialysis
• • Presence of a mechanical tricuspid valve prosthesis
• • Unwilling or unable to comply fully with study procedures and follow-up