Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector (FRIENDS)

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).

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Ventricular Arrythmia; ICD; Lead
• Intervention / Treatment: Device: Implant of the INVICTA lead

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 .

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHU
  • Clermont-Ferrand, France, 63003
    • CHU
  • Valence, France, 26000
    • CH de Valence
• Italy
  • Bergamo, Italy, 24125
    • Cliniche Humanitas Gavazzeni
  • Messina, Italy, 98124
    • Ospedale Piemonte (IRCCS Bonino Pulejo)
• Portugal
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar de Lisboa Norte - Santa Maria
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Girona, Spain, 17190
    • Hospital Universitari de Girona Doctor Josepj Trueta
  • Malaga, Spain, 2901
    • Hospital Virgen de la Victoria
  • Hospitalet De Llobregat
    • Barcelona, Hospitalet De Llobregat, Spain
      • Hospital De Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from INVICTA lead-related complications	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.	90 days
INVICTA lead electrical performance at 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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
INVICTA lead pacing threshold	RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width	24 months
INVICTA lead impedances	RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D	24 months
INVICTA sensing threshold	RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D	24 months
Percentage of the shocks that successfully terminate a ventricular arrhythmia episode	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.	24 months
INVICTA lead complication free-rate up to 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	24 months
INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months	Report of INVICTA lead-related SADEs and device deficiencies occurred up to 24 months post-implantation	24 months
INVICTA lead handling assessment	Summary of the investigators' opinion about INVICTA handling at implant	At Implant (Day 0)
INVICTA lead implant success rate	% of enrolled patients successfully implanted with an INVICTA lead	At Implant (Day 0)

Collaborators and Investigators

• Sponsor: MicroPort CRM
• Investigators: Principal Investigator: Pedro MARQUES, MD, Hospital de Santa Maria - Lisboa - Portugal

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: ICD; Lead; CRT-D; INVICTA; MicroPort
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LNC001; CIV-PT-18-08-025366 (Other Identifier: INFARMED (Eudamed code))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No