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Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Sponsor: MicroPort CRM

NCT ID: NCT05165095

View on ClinicalTrials.gov ↗

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.

BradycardiaRemote Monitoring

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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

Where Is This Study? (3 UK sites)

Basildon University Hospital

Basildon, United Kingdom

NOT_YET_RECRUITING

Kingston Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Charlotte Morrison

khft.researchgovernance@nhs.net020 8934 2803 / 2804

Southend University Hospital

Westcliff-on-Sea, United Kingdom

Recruiting

How to Get in Touch

Antoine Guihard

Sponsor contact

CONTACT

+33 1 46 01 33 20 antoine.guihard@crm.microport.com
Data sourced from ClinicalTrials.gov · Last verified: 2024-05