At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- Mostly remote — few or no hospital visits
- Drug or intervention
- Pacemaker implantation (device)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- Pacemaker implantation — device: De novo implantation, device upgrade to dual chamber or device replacement
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at remote monitoring features in pacemakers for people with bradycardia (a slower than normal heart rate). It involves pacemakers made by MicroPort CRM. The study checks how well certain remote monitoring functions work.
Who can take part
- You had a pacemaker fitted (new, upgraded to dual chamber, or replaced) within the last 20 days, following current European guidelines
- Your pacemaker is an ALIZEA, BOREA or CELEA dual chamber model made by MicroPort CRM
- Your leads (wires) in the right atrium and right ventricle (the heart's upper and lower right chambers) are approved CE-marked types
- You have agreed to have the remote monitoring functions switched on
- You have read, understood and signed the informed consent form
Who may not be able to
- You need a higher than usual amount of energy to pace the right ventricle (above 2.0 V at a pulse width of 0.5 ms or less)
- You have permanent atrial fibrillation (a constant irregular heart rhythm)
- You are already taking part in another study that could affect this study's results
- You were fitted with a device despite reasons not to have a pacemaker, or you have certain tricuspid heart valve problems, or you cannot have a single 310 microgram dose of a steroid medicine called dexamethasone sodium phosphate
- You are under 18 years old
- You cannot take part fully, are under guardianship, are detained, or cannot understand the study's purpose
- You cannot attend the planned follow-up visits
- You are a woman who has not yet gone through the menopause
What taking part involves
- • Having your pacemaker's remote monitoring functions activated, including remote alerts and two functions called RAAT and RVAT
- • Not stated — ask the trial team about any other tests or procedures
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 206
- Started
- 2022-03-25
- Last checked
- 2024-05
Plain English Summary
What is this study?
- • Testing a new treatment for bradycardia
- • Clinical study - 206 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with bradycardia
Where?
- • Basildon - Basildon University Hospital
- • London - Kingston Hospital
- • Westcliff-on-Sea - Southend University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
All patients will be included just after implantation and will then be followed during 48 months after inclusion. 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation,...
- ✓Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
- ✓Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar...
- ✓Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by...
- ✓Patient reviewed, signed and dated the ICF
Who cannot take part
- ✗Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
- ✗Patient with permanent AF
- ✗Patient already enrolled in another clinical investigation that could confound the results of this clinical...
- ✗Minor age patient (i.e. under 18 years of age)
- ✗Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the...
See the full criteria
Where Is This Study? (3 UK sites)
Basildon University Hospital
Basildon, United Kingdom
Kingston Hospital
London, United Kingdom
Southend University Hospital
Westcliff-on-Sea, United Kingdom
How to Get in Touch
Antoine Guihard
Sponsor contactCONTACT
