Assessing remote monitoring functions in pacemakers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Antoine Guihard
• Email: antoine.guihard@crm.microport.com
• Phone: +33 1 46 01 33 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.