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

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Sudden Cardiac Death; Cardiac Rhythm Disorder
• Intervention / Treatment: Device: Implantation of a CIED

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 Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Hanan FAWAZ, MSC; Phone Number: 33616531960; Email: hanan.fawaz@crm.microport.com

Study Locations

• Portugal
  • Lisboa, Portugal
    • Recruiting
    • Hospital Santa Marta Lisboa
    • Contact: Mario Olivera, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects implanted with a pacemaker, an Implantable Cardioverter-Defibrillator (ICD) or a Cardiac Resynchronization Therapy (CRT-D) Class I or II indication according to the latest guidelines from the European Society of Cardiology (ESC)1 or from the American College of Cardiology (ACC)/ American Heart Association (AHA)/ Heart Rhythm society (HRS)2 as appropriate per geography.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pacemaker system; Patients implanted with ENO or ALIZEA family pacing systems	Device: Implantation of a CIED; Implantation of a CIED
ICD system; Patients implanted with ULYS family ICD systems	Device: Implantation of a CIED; Implantation of a CIED
CRT-D system; Patients implanted with GALI family CRT-D systems	Device: Implantation of a CIED; Implantation of a CIED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: MicroPort CRM
• Investigators: Study Director: Yann POEZEVARA, MSc, MicroPort CRM

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): June 15, 2031
• Study Completion (Estimated): June 15, 2031

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Arrhythmias, Cardiac; Death, Sudden, Cardiac
• Other Study ID Numbers: LMIO01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No