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NCT05694572 | Recruiting | Cardiac Rhythm Disorder

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Sponsor:

MicroPort CRM

Brief Summary:

The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.

Condition or disease

Cardiac Rhythm Disorder

Heart Failure

Sudden Cardiac Death

Intervention/treatment

Implantation of a CIED

Detailed Description:

PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CE- market and released since 2018. Continuous monitoring of MicroPort CRM market-released systems will also enable to: confirm the safety and performance of the device throughout the study duration identify previously unknown side-effects and monitoring the identified side-effects and contraindications, identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct}}

Study Type : Observational
Estimated Enrollment : 2500 participants
Official Title : Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Actual Study Start Date : October 30, 2023
Estimated Primary Completion Date : June 15, 2031
Estimated Study Completion Date : June 15, 2031

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study
    • 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
      • Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
      • Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
      • 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
        • Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
        • Life expectancy less than 1 year
        • Currently enrolled in an active study of MicroPort CRM
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Location Details

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Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Portugal,

Santa Marta Lisbon Hospital

Lisboa, Portugal,