Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorMicroPort CRM
About this trial
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
Life expectancy less than 1 year
Currently enrolled in an active study of MicroPort CRM
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Implantation of a CIED
DeviceImplantation of a CIED
Treatment groups
2,500 Participants
are divided into 3 treatment groupsGroup A: Pacemaker system1 intervention
Group B: ICD system1 intervention
Group C: CRT-D system1 intervention
Trial outcomes
Primary outcomes
1
Chronic complication free rate of MicroPort CRM market-released system
Complications are defined as device-related reinterventions or deaths
Time frame
Through study duration, an average of 5 yearsSecondary outcomes
1
Acute complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame
Up to 3 months post-implant2
Overall complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame
Through study duration, an average of 5 years3
Annual complication free rate
Complications are defined as device-related reinterventions or deaths
Time frame
Through study duration, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov