Assessing remote monitoring functions in pacemakers
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
This study is testing how well remote monitoring features in certain pacemakers work to keep patients safe over four years after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MicroPort CRM Industry-sponsored |
| Locations | 19 sites (Krems and 18 other locations) |
| Trial ID | NCT05165095 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the safety and performance of remote monitoring functions in the ALIZEA, BOREA, and CELEA pacemakers. Patients will be monitored for 48 months following implantation, with assessments conducted during scheduled follow-up visits. The study will measure the effectiveness of remote alerts and other monitoring features, ensuring patient safety throughout the duration of the investigation.
Who should consider this trial
Good fit: Ideal candidates include patients who have recently received an ALIZEA, BOREA, or CELEA dual chamber pacemaker and are eligible for remote monitoring.
Not a fit: Patients with elevated RV pacing thresholds, permanent atrial fibrillation, or those enrolled in conflicting clinical investigations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of patients with bradycardia by improving the effectiveness of remote monitoring in pacemakers.
How similar studies have performed: Previous studies have shown promise in remote monitoring of cardiac devices, suggesting potential for success in this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement) 2. Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM 3. Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead 4. Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by the patient and planned to be activated 5. Patient reviewed, signed and dated the ICF Exclusion Criteria: 1. Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below) 2. Patient with permanent AF 3. Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device) 4. Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery) 5. Minor age patient (i.e. under 18 years of age) 6. Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation 7. Patient unavailable for the follow-up visits scheduled 8. Non-menopausal women
Where this trial is running
Krems and 18 other locations
- Universitätsklinikum Krems — Krems, Austria (Recruiting)
- Allgemeines Krankenhaus Wien — Vienna, Austria (Recruiting)
- Clinique Saint Joseph — Arlon, Belgium (Recruiting)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- CH Chartres — Le Coudray, France (Recruiting)
- CHU Hôpital de la Timone — Marseille, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- Clinique Pasteur Toulouse — Toulouse, France (Recruiting)
- CH Valence — Valence, France (Recruiting)
- Cardiologicum Hamburg — Hamburg, Germany (Recruiting)
- Cardiologicum Pirna — Pirna, Germany (Recruiting)
- Kardiologische Praxis Dr. Trautwein & Dr. Placke — Rostock, Germany (Recruiting)
- Ziekenhuis VieCuri Venlo — Venlo, Netherlands (Recruiting)
- Hospital Professor Doutor Fernando Fonseca — Amadora, Portugal (Recruiting)
- Hospital Arquitecto Marcide — Ferrol, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Majadahonda, Spain (Recruiting)
- Basildon University Hospital — Basildon, United Kingdom (Not_yet_recruiting)
- Kingston Hospital — London, United Kingdom (Recruiting)
- Southend University Hospital — Westcliff-on-Sea, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Antoine Guihard
- Email: antoine.guihard@crm.microport.com
- Phone: +33 1 46 01 33 20
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.