Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices (PIANO)

MicroPort

Status: Enrolling

Conditions: Cardiac Rhythm Disorder; Heart Failure; Sudden Cardiac Death

Treatments: Device: Implantation of a CIED

Study type: Observational

Funder types: Industry

Identifiers

NCT05694572

LMIO01

Details and patient eligibility

About

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

Full 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

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 3 patient groups

Pacemaker system

Description:

Patients implanted with ENO or ALIZEA family pacing systems

Treatment:

Device: Implantation of a CIED

ICD system

Description:

Patients implanted with ULYS family ICD systems

Treatment:

Device: Implantation of a CIED

CRT-D system

Description:

Patients implanted with GALI family CRT-D systems

Treatment:

Device: Implantation of a CIED