Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-30

Study Completion Date

2031-06-15

Brief Summary

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

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Detailed Description

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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

Conditions

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Cardiac Rhythm Disorder Heart Failure Sudden Cardiac Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pacemaker system

Patients implanted with ENO or ALIZEA family pacing systems

Implantation of a CIED

Intervention Type DEVICE

Implantation of a CIED

ICD system

Patients implanted with ULYS family ICD systems

Implantation of a CIED

Intervention Type DEVICE

Implantation of a CIED

CRT-D system

Patients implanted with GALI family CRT-D systems

Implantation of a CIED

Intervention Type DEVICE

Implantation of a CIED

Interventions

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Implantation of a CIED

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No