Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death
Conditions
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
Interventions
DEVICEImplantation of a CIED
Implantation of a CIED
Sponsors
MicroPort CRM
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Acute complication free rate | Up to 3 months post-implant | Complications are defined as device-related reinterventions or deaths |
| Overall complication free rate | Through study duration, an average of 5 years | Complications are defined as device-related reinterventions or deaths |
| Annual complication free rate | Through study duration, an average of 1 year | Complications are defined as device-related reinterventions or deaths |
Countries
Portugal
Contacts
Primary ContactHanan FAWAZ, MSC
Outcome results
None listed