Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
NCT ID: NCT05165095
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
206 participants
OBSERVATIONAL
2022-03-25
2027-07-31
Brief Summary
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Detailed Description
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At each on-site or remote follow-up visit (1 to 3 months, 6, 12, 24 and 48 months), performances of the remote monitoring functions and the cardiac pacing system itself will be measured, and safety will be monitored during the whole clinical investigation duration.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Pacemaker implantation
De novo implantation, device upgrade to dual chamber or device replacement
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Locations
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Universitätsklinikum Krems
Krems, , Austria
Allgemeines Krankenhaus Wien
Vienna, , Austria
Clinique Saint Joseph
Arlon, , Belgium
CHU Bordeaux
Bordeaux, , France
CH Chartres
Le Coudray, , France
CHU Hôpital de la Timone
Marseille, , France
CHU Nantes
Nantes, , France
Clinique Pasteur Toulouse
Toulouse, , France
CH Valence
Valence, , France
Cardiologicum Hamburg
Hamburg, , Germany
Cardiologicum Pirna
Pirna, , Germany
Kardiologische Praxis Dr. Trautwein & Dr. Placke
Rostock, , Germany
Ziekenhuis VieCuri Venlo
Venlo, , Netherlands
Hospital Professor Doutor Fernando Fonseca
Amadora, , Portugal
Hospital Arquitecto Marcide
Ferrol, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Basildon University Hospital
Basildon, , United Kingdom
Kingston Hospital
London, , United Kingdom
Southend University Hospital
Westcliff-on-Sea, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Daniel Gerger
Role: primary
Marianne Gwechenberger
Role: primary
Georges Mairesse
Role: primary
Marc Strik
Role: primary
Hervé Gorka
Role: primary
Jean-Claude Deharo
Role: primary
Vincent Probst
Role: primary
Romain Cassagneau
Role: primary
Alexandre Guignier
Role: primary
Martin Bergmann
Role: primary
Christoph Axthelm
Role: primary
Jens Placke
Role: primary
Ronald Hazeleger
Role: primary
Francisco Madeira
Role: primary
Fernando Garcia López
Role: primary
Ignacio Fernandez-Lozano
Role: primary
Neil Srinivasan
Role: primary
Simon Pearse
Role: primary
Neil Srinivasan
Role: primary
Other Identifiers
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IPBI01 - CALLIOPE
Identifier Type: -
Identifier Source: org_study_id
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