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| Name | Class |
|---|---|
| University of Bern | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional pacemaker DDD | Active Comparator | Implantation of a conventional dual-chamber PM |
|
| Leadless pacemaker Micra AV | Active Comparator | Implantation of a leadless pacemaker system (Micra AV™) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional pacemaker DDD | Device | Implantation of a conventional cardiac pacemaker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Exercise capacity (VO2 at anaerobic threshold) as assessed by spiroergometry | Month 3 post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Total implantation time | Total implantation time | During implantation on day 0 |
| Total fluoroscopy time | Total fluoroscopy time during implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Häberlin, MD | Inselspital, Bern University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital, Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23801822 | Background | Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available. |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D054537 | Atrioventricular Block |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
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| Leadless pacemaker Micra AV | Device | Implantation of a leadless cardiac pacemaker |
|
| During implantation on day 0 |
| Total fluoroscopy dosage | Total fluoroscopy dosage during implantation | During implantation on day 0 |
| Pacing thresholds | Pacing thresholds of the implanted pacemaker | Days 0,1 and months 1,3,12 and 24 post implantation |
| Sensing values | Sensing values of the implanted pacemaker | Days 0,1 and months 1,3,12 and 24 post implantation |
| Impedance values | Impedance values of the implanted pacemaker | Days 0,1 and months 1,3,12 and 24 post implantation |
| Duration of exercise | Duration of exercise until exhaustion assessed by spiroergometry | Month 3 post implantation |
| VO2max | VO2max assessed by spiroergometry | Month 3 post implantation |
| VE/VCO2 | VE/VCO2 assessed by spiroergometry | Month 3 post implantation |
| VE/VO2 | VE/VO2 assessed by spiroergometry | Month 3 post implantation |
| Maximum atrial heart rate | Maximum atrial heart rate as assessed by spiroergometry | Month 3 post implantation |
| Left ventricular ejection fraction (LVEF) | LVEF as assessed by echocardiography | Day 0 and months 3, 12 and 24 post implantation |
| Degree of tricuspid valve regurgitation | 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" | Day 0 and months 3, 12 and 24 post implantation |
| Degree of mitral valve regurgitation | 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" | Day 0 and months 3, 12 and 24 post implantation |
| Quality of Life scores measured with the EQ-5D-5L Questionnaire | 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 | Days 0,1 and months 1,3,12 and 24 post implantation |
| AV synchrony | Day 1 and months 1,3,12 and 24 post implantation |
| Laboratory | NT-proBNP | Day 0 and month 3 post implantation |
| Safety outcomes | 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 | Days 0,1 and months 1,3,12 and 24 post implantation |