Status:
UNKNOWN
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
Lead Sponsor:
MicroPort CRM
Conditions:
Ventricular Arrythmia
Lead
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
FRIENDS study is a pre-market approval (INVICTA leads - devices under investigation - are not CE marked), interventional, prospective, longitudinal, international (European), multicenter, single arm s...
Eligibility Criteria
Inclusion
- Any patient presenting an ICD or CRT-D indication as detailed in the latest European Society of Cardiology (ESC) guidelines
- Scheduled for a primary implant of an ICD / CRT-D, manufactured by MicroPort CRM and equipped with a RV DF4 connector
- Signed and dated informed consent
Exclusion
- Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue)
- Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock)
- Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP)
- Active myocarditis
- Already included in another clinical study that could confound the results of this study
- Inability to understand the purpose of the study or to meet follow-up visits at the implanting centre as defined in the investigational plan
- Patient less than 18 years old or under guardianship or kept in detention
- Known pregnancy, women in breastfeeding or in childbearing age without an adequate contraceptive method
- Drug addiction or abuse
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03766919
Start Date
December 27 2018
End Date
March 1 2021
Last Update
April 16 2019
Active Locations (10)
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1
CHU
Brest, France, 29200
2
CHU
Clermont-Ferrand, France, 63003
3
CH de Valence
Valence, France, 26000
4
Cliniche Humanitas Gavazzeni
Bergamo, Italy, 24125