NCT05165095 Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
| NCT ID | NCT05165095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MicroPort CRM |
| Condition | Bradycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 206 participants |
| Start Date | 2022-03-25 |
| Primary Completion | 2023-09-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 206 participants in total. It began in 2022-03-25 with a primary completion date of 2023-09-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05165095 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05165095 currently recruiting?
Yes, NCT05165095 is actively recruiting participants. Contact the research team at antoine.guihard@crm.microport.com for enrollment information.
Where is the NCT05165095 trial being conducted?
This trial is being conducted at Krems, Austria, Vienna, Austria, Arlon, Belgium, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT05165095 clinical trial?
NCT05165095 is sponsored by MicroPort CRM. The trial plans to enroll 206 participants.