Clinical trial NCT05694572: Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Official title: Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Rhythm Disorder
Heart Failure
Sudden Cardiac Death
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Chronic complication free rate of MicroPort CRM market-released system
timeFrame: Through study duration, an average of 5 years
Secondary outcomes:
measure: Acute complication free rate
timeFrame: Up to 3 months post-implant
measure: Overall complication free rate
timeFrame: Through study duration, an average of 5 years
measure: Annual complication free rate
timeFrame: Through study duration, an average of 1 year
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital Santa Marta Lisboa
Study officials:
affiliation: MicroPort CRM
name: Yann POEZEVARA, MSc
role: STUDY_DIRECTOR
References: