Actively Recruiting
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Led by MicroPort CRM · Updated on 2024-05-31
206
Participants Needed
19
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of remote monitoring functions in ALIZEA, BOREA, and CELEA pacemakers for patients with bradycardia. This observational clinical investigation focuses on the devices Right Atrial Autothreshold RAAT, Right Ventricular Autothreshold RVAT, and remote alert features. The study aims to document these functions over time to better understand their reliability and safety. Participants will be included soon after pacemaker implantation and followed for 48 months. Follow-up visits occur both on-site and remotely at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion. During these visits, the remote monitoring functions and the pacing systems performance will be measured, and safety will be continuously monitored throughout the study. Throughout the study, researchers will assess cardiac pacing thresholds, technical remote alerts, and the usability of the pacemaker and remote monitoring systems. Evaluations include Right Atrial and Right Ventricular pacing thresholds at multiple timepoints up to 48 months. Participants will undergo scheduled check-ins involving measurements, monitoring, and safety assessments, with the total study duration lasting four years after enrollment.
CONDITIONS
Brief Title
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient implanted according to the most recent ESC guidelines within 20 days (including new implant, device upgrade to dual chamber, or device replacement)
- Patient implanted with an ALIZEA, BOREA, or CELEA dual chamber pacemaker from MicroPort CRM
- Patient implanted with any active or passive CE marked bipolar right atrial and right ventricular leads
- Patient agrees to have the pacemaker's remote monitoring functions (RAAT, RVAT, and remote alerts) activated
- Patient has reviewed, signed, and dated the informed consent form
You will not qualify if you...
- Patient with right ventricular pacing threshold strictly above 2.0 V at 0.5 ms pulse width
- Patient with permanent atrial fibrillation
- Patient enrolled in another clinical investigation that might confuse results, such as those involving intracardiac devices
- Patient implanted despite contraindications for cardiac pacing system implantation (e.g., defibrillator implantation, contraindication to dexamethasone sodium phosphate, tricuspid valve replacement or significant tricuspid valve disease)
- Patient under 18 years of age
- Patient who is incapacitated, under guardianship, detained, refuses cooperation, or cannot understand the study purpose
- Patient unavailable for scheduled follow-up visits
- Non-menopausal women
Research Team
A
Antoine Guihard
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