Actively Recruiting
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Led by MicroPort CRM · Updated on 2024-05-31
206
Participants Needed
19
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient implanted according to the most recent ESC guidelines for 20 days or less (new implant, upgrade to dual chamber, or device replacement)
- Patient implanted with an ALIZEA, BOREA, or CELEA dual chamber pacemaker from MicroPort CRM
- Patient implanted with any active or passive CE marked bipolar right atrial lead and right ventricular lead
- Patient's pacemaker remote monitoring functions (RAAT, RVAT, remote alerts) accepted by the patient and planned to be activated
- Patient has reviewed, signed, and dated the informed consent form
You will not qualify if you...
- Patient with right ventricular pacing threshold above 2.0 V at 0.5 ms pulse width
- Patient with permanent atrial fibrillation
- Patient enrolled in another clinical investigation that could affect study results
- Patient implanted despite contraindications for cardiac pacing system implantation (including defibrillator, dexamethasone sodium phosphate allergy, tricuspid valve replacement or disease)
- Patients under 18 years of age
- Incapacitated patients, under guardianship, detained, refusing cooperation, or unable to understand study purpose
- Patient unavailable for scheduled follow-up visits
- Non-menopausal women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Universitätsklinikum Krems
Krems, Austria
Actively Recruiting
2
Allgemeines Krankenhaus Wien
Vienna, Austria
Actively Recruiting
3
Clinique Saint Joseph
Arlon, Belgium
Actively Recruiting
4
CHU Bordeaux
Bordeaux, France
Actively Recruiting
5
CH Chartres
Le Coudray, France
Actively Recruiting
6
CHU Hôpital de la Timone
Marseille, France
Actively Recruiting
7
CHU Nantes
Nantes, France
Actively Recruiting
8
Clinique Pasteur Toulouse
Toulouse, France
Actively Recruiting
9
CH Valence
Valence, France
Actively Recruiting
10
Cardiologicum Hamburg
Hamburg, Germany
Actively Recruiting
11
Cardiologicum Pirna
Pirna, Germany
Actively Recruiting
12
Kardiologische Praxis Dr. Trautwein & Dr. Placke
Rostock, Germany
Actively Recruiting
13
Ziekenhuis VieCuri Venlo
Venlo, Netherlands
Actively Recruiting
14
Hospital Professor Doutor Fernando Fonseca
Amadora, Portugal
Actively Recruiting
15
Hospital Arquitecto Marcide
Ferrol, Spain
Actively Recruiting
16
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Actively Recruiting
17
Basildon University Hospital
Basildon, United Kingdom
Not Yet Recruiting
18
Kingston Hospital
London, United Kingdom
Actively Recruiting
19
Southend University Hospital
Westcliff-on-Sea, United Kingdom
Actively Recruiting
Research Team
A
Antoine Guihard
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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