Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death Heart Diseases, Cardiovascular Diseases, Heart Arrest Death, Sudden Death, Sudden, Cardiac Arrhythmias, Cardiac Death
Conditions
Interventions
Echocardiography performed within 1 week and 1 year post CRTD implantation in the SonR substudy
Echocardiography
Sponsors
Yusuke Kondo
Amblard Amel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the Piano global study (Observational study) 1 Subject implanted with one of the following MicroPort CRM market-released system: a ENO, TEO, OTO, ALIZEA, BOREA, or CELEA pacemaker Single chamber (SR) or Dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead. b ULYS, EDIS implantable Cardioverter Defibrillator single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional. c GALI Cardiac Resynchronization Therapy-Defibrillator implanted in combination with an INVICTA defibrillation lead and a NAVIGO left ventricular pacing lead. Additional XFINE or VEGA atrial pacing lead is optional. d GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular and/or a SONRTIP atrial pacing lead. e 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) or RMS accepted by subject and planned to be activated (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. Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the SonR sub study (Interventional study) 1 Subjects successfully implanted within one week with a GALI SonR CRT-D system in combination with a SonRTip RA pacing lead and INVICTA defibrillation lead. NAVIGO LV pacing lead is optional. c Future generation of market approved MicroPort CRM SonR CRT-D device associated with existing or future generation of MicroPort CRM lead. 2 Subjects in sinus rhythm at time of inclusion. 3 Subject equipped with Remote Monitoring System (RMS) or RMS accepted by subject and planned to be activated. 4 Subject followed yearly per standard practice by investigational site: on-site visit at inclusion and one-year follow-up visits and on-site or remote visit through remote monitoring system through study duration. 5 Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation.
Exclusion criteria
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 |
|---|---|
| The primary endpoint of PIANO is the chronic complication free rate of MicroPort CRM market-released system. Chronic duration is the timeframe from 3 months post-implant to study end. Complication is defined as device-related re-intervention or death per sponsor assessment. Re-intervention related to Infection and hematoma will not be considered for this endpoint. Re-intervention in the context of normal device behavior (e.g, device upgrade, replacement for normal battery depletion, alternative treatment option) will not be considered for this endpoint. Primary endpoint is descriptive and will be assessed on individual devices for all subjects enrolled within 3 months post-implant 1 per device (generator and lead) model 2 per cardiac chamber Right Atrium and Right Ventricle for pacing leads implantable in more than one chamber | — |
Secondary
| Measure | Time frame |
|---|---|
| PIANO secondary endpoints are the monitoring of the safety and the performances of MicroPort CRM market-released systems at different time points of the study conduct. Safety secondary endpoints Descriptive analysis of 1 Complication: Acute, overall and annual Chronic, overall and annual description of 2 Serious Adverse Device Effect (SADE) 3 Individual component of SADE a Re-intervention b Death c Hospitalization 4 All causes death 5 Infection that led to SADE 6 Hematoma that led to SADE 7 Lead electrically abandoned 8 Inappropriate therapy leading to SADE for ICD and CRT-D systems Acute duration is the timeframe from implant to 3 months post-implant. Chronic duration is the timeframe from 3 months post-implant to study end. Overall duration is the timeframe from implant to study end. Complication definition is the same as the primary endpoint. Re-intervention in the context of normal device behavior (e.g, device upgrade, replacement for normal battery depletion, alternative treatment option) will not be considered for secondary endpoints. Performance secondary endpoints: Yearly follow-up through study duration 1 Lead performances, pacing capture threshold, impedance and sensed amplitude measurements 2 Generator performances a Total implant longevity b Percentage of Biventricular pacing for CRT-D Secondary endpoints will be described 1 per device (generator and lead) model 2 per cardiac chamber (RA and RV) for pacing leads implantable in more than one chamber SonR Sub study 1 Correspondence of clinical response to the SonR CRT-D optimization at 1-year post-inclusion vs mechanical resynchronization at inclusion. 2 Heart Failure-related hospitalization rate at 1-year post-inclusion compared to 1-year pre-inclusion. 3 Assessment of the LV Reverse remodeling at 1-year post-inclusion (Structural remodeling). 4 Mechanical resynchronization at 1-year post-inclusion | — |
Countries
Austria, France, Germany, Italy, Japan, Portugal, Spain, The United Kingdom
Contacts
Public ContactKondo Yusuke
Chiba University Hospital
Outcome results
None listed