Comparing leadless and transvenous pacing in elderly patients with AV block
Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block
This study is testing whether a new leadless pacemaker or a traditional one works better for older patients with heart block in terms of their quality of life and ability to exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus, Region Midt and 1 other locations) |
| Trial ID | NCT05856799 on ClinicalTrials.gov |
What this trial studies
This study evaluates the quality of life, patient acceptance, and exercise capacity in elderly patients with new-onset high-grade atrioventricular block who require permanent pacemaker implantation. Participants will be randomly assigned to receive either a leadless Micra AV Transcatheter Pacing System or a transvenous Azure XT DR dual chamber pacemaker. The trial is designed to be partly blinded and will assess outcomes related to both pacing methods over time.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 75 years or older with intact sinus node function and a need for first-time pacemaker implantation due to high-grade AV block.
Not a fit: Patients with previous cardiac devices, chronic atrial fibrillation, or severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life and acceptance of pacing methods for elderly patients with AV block.
How similar studies have performed: Other studies have shown promising results with leadless pacing technologies, suggesting potential benefits over traditional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing \>80% of the time, * Age 75 years or older * Intact sinus node function * Expected survival more than 12 months based on clinical evaluation * Able to provide informed consent Exclusion criteria: * Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT. * Persistent, or chronic atrial fibrillation * Reversible AVB * Transient AVB due to ongoing ischemia * Heart failure NYHA class III-IV * Heart failure with branch block and indication for CRT implantation, irrespective of NYHA class * Indication for primary or secondary prophylactic ICD implantation * Acute myocardial infarction (AMI) within 3 months * Severe chronic pulmonary disease with pulmonal hypertension limiting exercise capacity * Expected survival \< 12 months based on clinical evaluation * Performing high intensity sport * Participation in another trial with experimental treatment * Contraindication against device implantation (e.g., concurrent infection) * Failure to provide informed consent
Where this trial is running
Aarhus, Region Midt and 1 other locations
- Department of Cardiology Aarhus University Hospital — Aarhus, Region Midt, Denmark (Recruiting)
- Department of Cardiology Odense University Hospital — Odense, Region Syd, Denmark (Recruiting)
Study contacts
- Principal investigator: Mads B. Kronborg, DMSc — Department of Cardiology Aarhus University Hospital
- Study coordinator: Henrik L. Bjerre, MD
- Email: henrikbjerre@clin.au.dk
- Phone: 30311345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.