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Clinical Trials in the Netherlands / NCT05165095
Recruiting Observational

Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

NCT05165095 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2022-03-25
Last updated
2024-05-31

Condition(s) studied

BradycardiaRemote Monitoring

Investigational drug(s) / intervention(s)

Pacemaker implantation

Pacemaker implantation: De novo implantation, device upgrade to dual chamber or device replacement

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
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

More MicroPort CRM trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05165095 on ClinicalTrials.gov ↗ ← All trials in the Netherlands