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

Heart Failure Clinical Trial

— FRIENDS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03766919
• Other study ID #: LNC001
• Secondary ID: CIV-PT-18-08-025
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 27, 2018
• Est. completion date: March 2021

Study information

• Verified date: April 2019
• Source: MicroPort CRM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• ICD
• Lead
• Ventricular Arrythmia

Intervention

Device:
• Implant of the INVICTA lead
The implant or the attempt to implant an INVICTA lead

Locations

Country	Name	City	State
France	CHU	Brest
France	CHU	Clermont-Ferrand
France	CH de Valence	Valence
Italy	Cliniche Humanitas Gavazzeni	Bergamo
Italy	Ospedale Piemonte (IRCCS Bonino Pulejo)	Messina
Portugal	Centro Hospitalar de Lisboa Norte - Santa Maria	Lisboa
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital de Bellvitge	Barcelona	Hospitalet De Llobregat
Spain	Hospital Universitari de Girona Doctor Josepj Trueta	Girona
Spain	Hospital Virgen de la Victoria	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Countries where clinical trial is conducted

France,  Italy,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	INVICTA lead impedances	RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D	24 months
Secondary	INVICTA sensing threshold	RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	INVICTA lead handling assessment	Summary of the investigators' opinion about INVICTA handling at implant	At Implant (Day 0)
Secondary	INVICTA lead implant success rate	% of enrolled patients successfully implanted with an INVICTA lead	At Implant (Day 0)