Arrhythmias, Cardiac, Cardiac Pacemaker, Cardiovascular Diseases, Heart Diseases
Conditions
Keywords
Leadless pacemaker, Atrioventricular conduction block, Bradyarrhythmias, Micra
Brief summary
Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical stimuli to the heart ("pacing"). These leads are responsible for the vast majority of morbidity after implantation and PM failures. Therefore, a leadless PM system (Micra TPS™, Medtronic, United States) has been introduced a few years ago. This system overcomes the limitations of leads, however, the first generation of the Micra TPS™ only allowed sensing and pacing in the right ventricle. More recently, an upgraded version has been introduced and gained market approval (Micra AV, Medtronic, United States). According to published results from several clinical trials, this device allows sensing the atrial activity and, thus, timing the delivery of the ventricular pacing impulse in a physiological manner similar to a conventional dual-chamber PM with two leads. Clinical feasibility and safety for this concept have been established already. However, it is unclear if this translates into a direct clinical benefit for patients in comparison to conventional PM systems. The aim of this trial is to compare the therapeutic efficacy of the Micra AV™ PM and conventional dual-chamber PM systems in patients with intermittent or permanent atrioventricular conduction block and a PM indication according to the latest European guidelines. Thus, patients will be randomized to either a conventional dual-chamber PM implantation or the implantation of a leadless Micra AV™ system. Patients will be stratified for gender (female/male) and a priori estimated physical exercise capacity ("fit"/"unfit"). The primary outcome will be the physical exercise capacity of the patients. The null hypothesis with regards to the primary endpoint is that the leadless pacemaker arm shows an inferior VO2 anaerobic threshold than the conventional pacemaker arm. Hence the alternative hypothesis postulates that the leadless pacemaker arm shows a non-inferior VO2 anaerobic threshold compared to the conventional pacemaker arm. Rejection of the null hypothesis is needed to conclude non-inferiority.
Interventions
DEVICEConventional pacemaker DDD
Implantation of a conventional cardiac pacemaker
DEVICELeadless pacemaker Micra AV
Implantation of a leadless cardiac pacemaker
Sponsors
Insel Gruppe AG, University Hospital Bern
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | Month 3 post implantation | Exercise capacity (VO2 at anaerobic threshold) as assessed by spiroergometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total implantation time | During implantation on day 0 | Total implantation time |
| Total fluoroscopy time | During implantation on day 0 | Total fluoroscopy time during implantation |
| Total fluoroscopy dosage | During implantation on day 0 | Total fluoroscopy dosage during implantation |
| Pacing thresholds | Days 0,1 and months 1,3,12 and 24 post implantation | Pacing thresholds of the implanted pacemaker |
| Sensing values | Days 0,1 and months 1,3,12 and 24 post implantation | Sensing values of the implanted pacemaker |
| Impedance values | Days 0,1 and months 1,3,12 and 24 post implantation | Impedance values of the implanted pacemaker |
| Duration of exercise | Month 3 post implantation | Duration of exercise until exhaustion assessed by spiroergometry |
| VO2max | Month 3 post implantation | VO2max assessed by spiroergometry |
| VE/VCO2 | Month 3 post implantation | VE/VCO2 assessed by spiroergometry |
| VE/VO2 | Month 3 post implantation | VE/VO2 assessed by spiroergometry |
| Maximum atrial heart rate | Month 3 post implantation | Maximum atrial heart rate as assessed by spiroergometry |
| Left ventricular ejection fraction (LVEF) | Day 0 and months 3, 12 and 24 post implantation | LVEF as assessed by echocardiography |
| Degree of tricuspid valve regurgitation | Day 0 and months 3, 12 and 24 post implantation | Degree of tricuspid valve regurgitation assessed by trans-thoracic echocardiogram. The degree of tricuspid valve regurgitation will be classified as "none", "mild", "moderate" or "severe" |
| Degree of mitral valve regurgitation | Day 0 and months 3, 12 and 24 post implantation | Degree of mitral valve regurgitation assessed by trans-thoracic echocardiogram. The degree of mitral valve regurgitation will be classified as "none", "mild", "moderate" or "severe" |
| Quality of Life scores measured with the EQ-5D-5L Questionnaire | Days 0,1 and months 1,3,12 and 24 post implantation | Quality of Life scores measured with the EQ-5D-5L Questionnaire Scores: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with a 5-scale response option; current health state assessed with a number between 0 and 100 |
| AV synchrony | Day 1 and months 1,3,12 and 24 post implantation | — |
| Laboratory | Day 0 and month 3 post implantation | NT-proBNP |
| Safety outcomes | Days 0,1 and months 1,3,12 and 24 post implantation | Major adverse events (death, cardiac tamponade, any surgical reintervention, pocket/groin problems, lead/device dislocations; electrode noise, pacing impedance out of range (\<200 or \>2000Ω), failure to capture at maximum output, infections and thrombosis/embolism); rate of pacemaker syndrome developed by patients; rate of device upgrades/revisions required |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORAndreas Häberlin, MD
Inselspital, Bern University Hospital
Outcome results
None listed