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
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of remote monitoring functions in ALIZEA, BOREA, and CELEA pacemakers for patients with bradycardia. This observational clinical investigation focuses on the devices' Right Atrial Autothreshold (RAAT), Right Ventricular Autothreshold (RVAT), and remote alert features. The study aims to document these functions over time to better understand their reliability and safety. Participants will be included soon after pacemaker implantation and followed for 48 months. Follow-up visits occur both on-site and remotely at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months after inclusion. During these visits, the remote monitoring functions and the pacing system's performance will be measured, and safety will be continuously monitored throughout the study. Throughout the study, researchers will assess cardiac pacing thresholds, technical remote alerts, and the usability of the pacemaker and remote monitoring systems. Evaluations include Right Atrial and Right Ventricular pacing thresholds at multiple timepoints up to 48 months. Participants will undergo scheduled check-ins involving measurements, monitoring, and safety assessments, with the total study duration lasting four years after enrollment.
CONDITIONS
Brief 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 within 20 days (including new implant, device 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 and right ventricular leads
- Patient agrees to have the pacemaker's remote monitoring functions (RAAT, RVAT, and remote alerts) activated
- Patient has reviewed, signed, and dated the informed consent form
You will not qualify if you...
- Patient with right ventricular pacing threshold strictly above 2.0 V at 0.5 ms pulse width
- Patient with permanent atrial fibrillation
- Patient enrolled in another clinical investigation that might confuse results, such as those involving intracardiac devices
- Patient implanted despite contraindications for cardiac pacing system implantation (e.g., defibrillator implantation, contraindication to dexamethasone sodium phosphate, tricuspid valve replacement or significant tricuspid valve disease)
- Patient under 18 years of age
- Patient who is incapacitated, under guardianship, detained, refuses cooperation, or cannot understand the 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
Your Study Journey
Duration - Up to 20 days before pacemaker implantation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at or shortly after implantation
Duration - Day of implantation
Participants undergo pacemaker implantation, including new implantation, device upgrade, or replacement.
1 visit (in-person)
Duration - 48 months
Participants are followed for 48 months after pacemaker implantation. At scheduled on-site or remote follow-up visits, performances of remote monitoring functions and the pacemaker system are measured and safety is monitored.
Follow-up visits at 1 to 3 months, 6 months, 12 months, 24 months, and 48 months (in-person or remote)
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
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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