Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector (FRIENDS)
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|ClinicalTrials.gov Identifier: NCT03766919|
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Arrythmia Lead ICD Heart Failure||Device: Implant of the INVICTA lead||Not Applicable|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2022|
Experimental: INVICTA lead
All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead)
Device: Implant of the INVICTA lead
The implant or the attempt to implant an INVICTA lead
- Freedom from INVICTA lead-related complications [ Time Frame: 90 days ]Freedom from INVICTA lead-related complications as assessed by an independent events adjudicator and defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention.
- INVICTA lead electrical performance at 3 months [ Time Frame: 3 months ]Right Ventricular (RV) pacing threshold (V) of the INVICTA lead, measured by the implanted ICD/CRT-D with 0.5 ms pulse width
- INVICTA lead pacing threshold [ Time Frame: 24 months ]RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
- INVICTA lead impedances [ Time Frame: 24 months ]RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
- INVICTA sensing threshold [ Time Frame: 24 months ]RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D
- Percentage of the shocks that successfully terminate a ventricular arrhythmia episode [ Time Frame: 24 months ]Percentage of endocardial shock therapies that successfully terminate ventricular arrhythmia episodes, calculated as the proportion of successful shocks on the total number of shocks delivered during defibrillation testing or spontaneous ventricular arrhythmias.
- INVICTA lead complication free-rate up to 24 months [ Time Frame: 24 months ]Report of INVICTA lead complication free-rate (complication defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention) up to 24 months post-implantation
- INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months [ Time Frame: 24 months ]Report of INVICTA lead-related SADEs and device deficiencies occurred up to 24 months post-implantation
- INVICTA lead handling assessment [ Time Frame: At Implant (Day 0) ]Summary of the investigators' opinion about INVICTA handling at implant
- INVICTA lead implant success rate [ Time Frame: At Implant (Day 0) ]% of enrolled patients successfully implanted with an INVICTA lead
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766919
|Contact: Alberto BORRI BRUNETTO||+39 161 email@example.com|
|Principal Investigator:||Pedro MARQUES, MD||Hospital de Santa Maria - Lisboa - Portugal|