Danish Randomized Trial on Leadless vs Transvenous Pacing (NCT05856799) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Danish Randomized Trial on Leadless vs Transvenous Pacing
Denmark80 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.