Heart Failure Clinical Trial
Official title:
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
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).
FRIENDS study is a pre-market approval (INVICTA leads - devices under investigation - are not
CE marked), interventional, prospective, longitudinal, international (European), multicenter,
single arm study.
The devices under investigation, the INVICTA defibrillation leads, are new quadripolar leads,
to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy
Defibrillators (ICD/CRT-D).
This clinical study intends to demonstrate safety and electrical performances of the INVICTA
leads among the different models: active fixation either single coil (model 1CR) or dual coil
(model 2CR) and passive fixation, either single coil (model 1CT) or dual coil (model 2CT)
leads models. The clinical data will be used to support the application to CE marking of
INVICTA leads.
The primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints
will be evaluated up to 2 years post-implantation.
A maximum number of 224 patients will be enrolled in the study, in up to 60 centers in
Europe.
The follow-up visits are scheduled at hospital discharge, at 1 month, at 3 months, at 6
months, at 12 months, at 18 months and at 24 months, post-implant .
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