Informations générales (source: ClinicalTrials.gov)
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector (FRIENDS)
Interventional
N/A
MicroPort CRM (Voir sur ClinicalTrials)
décembre 2018
mars 2021
29 juin 2024
The primary objective of this study is to assess the safety and key electrical
performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models
(single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single
and dual coil: INVICTA 1CT, INVICTA 2CT).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH de Valence - 26000 - Valence - France | Contact (sur clinicalTrials) | ||||
| CHU - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU - 63003 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Any patient presenting an ICD or CRT-D indication as detailed in the latest European
Society of Cardiology (ESC) guidelines
2. Scheduled for a primary implant of an ICD / CRT-D, manufactured by MicroPort CRM and
equipped with a RV DF4 connector
3. Signed and dated informed consent
1. Any patient presenting an ICD or CRT-D indication as detailed in the latest European
Society of Cardiology (ESC) guidelines
2. Scheduled for a primary implant of an ICD / CRT-D, manufactured by MicroPort CRM and
equipped with a RV DF4 connector
3. Signed and dated informed consent
1. Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or
tissue)
2. Transient tachyarrhythmias due to reversible causes (such as drug intoxication,
electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or
electric shock)
3. Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate
(DSP)
4. Active myocarditis
5. Already included in another clinical study that could confound the results of this
study
6. Inability to understand the purpose of the study or to meet follow-up visits at the
implanting centre as defined in the investigational plan
7. Patient less than 18 years old or under guardianship or kept in detention
8. Known pregnancy, women in breastfeeding or in childbearing age without an adequate
contraceptive method
9. Drug addiction or abuse