Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Heart Failure Clinical Trial

— PIANO  

Official title:

Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694572
• Other study ID #: LMIO01
• Status: Recruiting
• Start date: October 30, 2023
• Est. completion date: June 15, 2031

Study information

• Verified date: January 2024
• Source: MicroPort CRM
• Contact: Hanan FAWAZ, MSC
• Phone: 33616531960
• Email: hanan.fawaz[@]crm.microport.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 15, 2031
• Est. primary completion date: June 15, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Rhythm Disorder
• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Device:
• Implantation of a CIED
Implantation of a CIED

Locations

Country	Name	City	State
Portugal	Hospital Santa Marta Lisboa	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic complication free rate of MicroPort CRM market-released system	Complications are defined as device-related reinterventions or deaths	Through study duration, an average of 5 years
Secondary	Acute complication free rate	Complications are defined as device-related reinterventions or deaths	Up to 3 months post-implant
Secondary	Overall complication free rate	Complications are defined as device-related reinterventions or deaths	Through study duration, an average of 5 years
Secondary	Annual complication free rate	Complications are defined as device-related reinterventions or deaths	Through study duration, an average of 1 year