Monitoring the safety of MicroPort CRM heart devices

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

This study is checking the long-term safety of MicroPort CRM heart devices to see how well they work and if there are any unexpected side effects for people who use them.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: MicroPort CRM (Industry-sponsored)
• Locations: 1 site (Lisbon)
• Trial ID: NCT05694572 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term safety of MicroPort CRM cardiac implantable electronic devices that have been on the market since 2018. It involves continuous monitoring to confirm device performance, identify unknown side effects, and analyze any emergent risks based on factual evidence. The study will also investigate any systematic misuse or off-label use of these devices to ensure they are being used as intended.

Who should consider this trial

Good fit: Ideal candidates include individuals who have been implanted with specific MicroPort CRM devices since January 2020.

Not a fit: Patients who do not have a MicroPort CRM device or those implanted with devices not specified in the study criteria may not benefit.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of cardiac devices for patients with heart rhythm disorders.

How similar studies have performed: Other post-market surveillance studies have shown success in monitoring device safety and performance, indicating that this approach is validated.

Eligibility criteria

Inclusion Criteria:

Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:

1. Subject implanted with one of the following MicroPort CRM market-released system:

   * ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead
   * ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional.
   * GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional.
   * GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead.
   * Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead
2. Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
3. Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
4. Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible to be enrolled in the study:

1. Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
2. Life expectancy less than 1 year
3. Currently enrolled in an active study of MicroPort CRM

Where this trial is running

Lisbon

• Hospital Santa Marta Lisboa — Lisbon, Portugal (Recruiting)

Study contacts

• Study coordinator: Hanan FAWAZ, MSC

Conditions Cardiac Rhythm Disorder; Heart Failure; Sudden Cardiac Death