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

• Sponsor: MicroPort CRM (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05694572
• Collaborator: (none)
• Enrollment: 2,500
• Anticipated Duration (Months): 96

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Rhythm Disorder; Heart Failure; Sudden Cardiac Death	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 2500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
• Anticipated Study Start Date: Jun 15, 2023
• Anticipated Primary Completion Date: Jun 15, 2031
• Anticipated Study Completion Date: Jun 15, 2031

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Acute complication free rate [Up to 3 months post-implant]

   Complications are defined as device-related reinterventions or deaths

2. Overall complication free rate [Through study duration, an average of 5 years]

   Complications are defined as device-related reinterventions or deaths

3. Annual complication free rate [Through study duration, an average of 1 year]

   Complications are defined as device-related reinterventions or deaths

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)

2. Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system

3. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• MicroPort CRM

Investigators

• Study Director: Yann POEZEVARA, MSc, MicroPort CRM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MicroPort CRM
• ClinicalTrials.gov Identifier: NCT05694572
• Other Study ID Numbers: LMIO01
• First Posted: Jan 23, 2023
• Last Update Posted: Jan 23, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Death, Sudden, Cardiac; Arrhythmias, Cardiac; Death

Study Results

No Results Posted as of Jan 23, 2023