Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Recruiting

• Conditions: Cardiac Rhythm Disorder; Heart Failure; Sudden Cardiac Death
• Interventions: Device: Implantation of a CIED

• Registration Number: NCT05694572
• Lead Sponsor: MicroPort CRM

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

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-23
• Study Start: 2023-10-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17
• Primary Completion: 2031-06-15
• Study Completion: 2031-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT-D system	Implantation of a CIED	Patients implanted with GALI family CRT-D systems
Pacemaker system	Implantation of a CIED	Patients implanted with ENO or ALIZEA family pacing systems
ICD system	Implantation of a CIED	Patients implanted with ULYS family ICD systems

Primary Outcome Measures

Name	Time	Method
Chronic complication free rate of MicroPort CRM market-released system	Through study duration, an average of 5 years	Complications are defined as device-related reinterventions or deaths

Secondary Outcome Measures

Name	Time	Method
Acute complication free rate	Up to 3 months post-implant	Complications are defined as device-related reinterventions or deaths
Overall complication free rate	Through study duration, an average of 5 years	Complications are defined as device-related reinterventions or deaths
Annual complication free rate	Through study duration, an average of 1 year	Complications are defined as device-related reinterventions or deaths

Trial Locations

Locations (1)

Hospital Santa Marta Lisboa; 🇵🇹 Lisboa, Portugal