Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Rhythm Disorder
- Sponsor
- MicroPort CRM
- Enrollment
- 2500
- Locations
- 1
- Primary Endpoint
- Chronic complication free rate of MicroPort CRM market-released system
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
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
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Chronic complication free rate of MicroPort CRM market-released system
Time Frame: Through study duration, an average of 5 years
Complications are defined as device-related reinterventions or deaths
Secondary Outcomes
- Acute complication free rate(Up to 3 months post-implant)
- Overall complication free rate(Through study duration, an average of 5 years)
- Annual complication free rate(Through study duration, an average of 1 year)