Clinical trial NCT03766919: Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
Official title: Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventricular Arrythmia
Lead
ICD
Heart Failure
Keywords: INVICTA
Lead
ICD
CRT-D
MicroPort
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).

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 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 .

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Freedom from INVICTA lead-related complications
timeFrame: 90 days
measure: INVICTA lead electrical performance at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: INVICTA lead pacing threshold
timeFrame: 24 months
measure: INVICTA lead impedances
timeFrame: 24 months
measure: INVICTA sensing threshold
timeFrame: 24 months
measure: Percentage of the shocks that successfully terminate a ventricular arrhythmia episode
timeFrame: 24 months
measure: INVICTA lead complication free-rate up to 24 months
timeFrame: 24 months
measure: INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months
timeFrame: 24 months
measure: INVICTA lead handling assessment
timeFrame: At Implant (Day 0)
measure: INVICTA lead implant success rate
timeFrame: At Implant (Day 0)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU
city: Clermont-Ferrand
country: France
facility: CHU
city: Valence
country: France
facility: CH de Valence
city: Bergamo
country: Italy
facility: Cliniche Humanitas Gavazzeni
city: Messina
country: Italy
facility: Ospedale Piemonte (IRCCS Bonino Pulejo)
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte - Santa Maria
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
state: Hospitalet De Llobregat
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josepj Trueta
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
Study officials:
affiliation: Hospital de Santa Maria - Lisboa - Portugal
name: Pedro MARQUES, MD
role: PRINCIPAL_INVESTIGATOR
References: