Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

NCT05694572 | Recruiting

• 1 other identifier: LMIO01
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Rhythm Disorder; Heart Failure; Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Acute complication free rate

  Up to 3 months post-implant

• Overall complication free rate

  Through study duration, an average of 5 years

• Annual complication free rate

  Through study duration, an average of 1 year

Study Arms (3)

Pacemaker system

Patients implanted with ENO or ALIZEA family pacing systems

Device: Implantation of a CIED

ICD system

Patients implanted with ULYS family ICD systems

Device: Implantation of a CIED

CRT-D system

Patients implanted with GALI family CRT-D systems

Device: Implantation of a CIED

Interventions

Implantation of a CIED DEVICE

Implantation of a CIED

CRT-D system; ICD system; Pacemaker system

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
• Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
• Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
• Life expectancy less than 1 year
• Currently enrolled in an active study of MicroPort CRM

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (1)

Hospital Santa Marta Lisboa

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Failure; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Officials

• Yann POEZEVARA, MSc

  MicroPort CRM

  STUDY DIRECTOR

Central Study Contacts

Hanan FAWAZ, MSC

CONTACT

33616531960; hanan.fawaz@crm.microport.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 23, 2023
• Study Start: October 30, 2023
• Primary Completion (Estimated): June 15, 2031
• Study Completion (Estimated): June 15, 2031
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

PT (1)