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

Primary Purpose

Ventricular Arrythmia, Lead, ICD

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implant of the INVICTA lead
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Arrythmia focused on measuring INVICTA, Lead, ICD, CRT-D, MicroPort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • CHU
  • CH de Valence
  • Cliniche Humanitas Gavazzeni
  • Ospedale Piemonte (IRCCS Bonino Pulejo)
  • Centro Hospitalar de Lisboa Norte - Santa Maria
  • Hospital de Bellvitge
  • Hospital General Universitario de Alicante
  • Hospital Universitari de Girona Doctor Josepj Trueta
  • Hospital Virgen de la Victoria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INVICTA lead

Arm Description

All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead)

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

INVICTA lead pacing threshold
RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
INVICTA lead impedances
RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
INVICTA sensing threshold
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
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
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
Report of INVICTA lead-related SADEs and device deficiencies occurred up to 24 months post-implantation
INVICTA lead handling assessment
Summary of the investigators' opinion about INVICTA handling at implant
INVICTA lead implant success rate
% of enrolled patients successfully implanted with an INVICTA lead

Full Information

First Posted
October 16, 2018
Last Updated
April 15, 2019
Sponsor
MicroPort CRM
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1. Study Identification

Unique Protocol Identification Number
NCT03766919
Brief Title
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
Acronym
FRIENDS
Official Title
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrythmia, Lead, ICD, Heart Failure
Keywords
INVICTA, Lead, ICD, CRT-D, MicroPort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INVICTA lead
Arm Type
Experimental
Arm Description
All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead)
Intervention Type
Device
Intervention Name(s)
Implant of the INVICTA lead
Intervention Description
The implant or the attempt to implant an INVICTA lead
Primary Outcome Measure Information:
Title
Freedom from INVICTA lead-related complications
Description
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.
Time Frame
90 days
Title
INVICTA lead electrical performance at 3 months
Description
Right Ventricular (RV) pacing threshold (V) of the INVICTA lead, measured by the implanted ICD/CRT-D with 0.5 ms pulse width
Time Frame
3 months
Secondary Outcome Measure Information:
Title
INVICTA lead pacing threshold
Description
RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
Time Frame
24 months
Title
INVICTA lead impedances
Description
RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
Time Frame
24 months
Title
INVICTA sensing threshold
Description
RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D
Time Frame
24 months
Title
Percentage of the shocks that successfully terminate a ventricular arrhythmia episode
Description
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.
Time Frame
24 months
Title
INVICTA lead complication free-rate up to 24 months
Description
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
Time Frame
24 months
Title
INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months
Description
Report of INVICTA lead-related SADEs and device deficiencies occurred up to 24 months post-implantation
Time Frame
24 months
Title
INVICTA lead handling assessment
Description
Summary of the investigators' opinion about INVICTA handling at implant
Time Frame
At Implant (Day 0)
Title
INVICTA lead implant success rate
Description
% of enrolled patients successfully implanted with an INVICTA lead
Time Frame
At Implant (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient presenting an ICD or CRT-D indication as detailed in the latest European Society of Cardiology (ESC) guidelines Scheduled for a primary implant of an ICD / CRT-D, manufactured by MicroPort CRM and equipped with a RV DF4 connector Signed and dated informed consent Exclusion Criteria: Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock) Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP) Active myocarditis Already included in another clinical study that could confound the results of this study Inability to understand the purpose of the study or to meet follow-up visits at the implanting centre as defined in the investigational plan Patient less than 18 years old or under guardianship or kept in detention Known pregnancy, women in breastfeeding or in childbearing age without an adequate contraceptive method Drug addiction or abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro MARQUES, MD
Organizational Affiliation
Hospital de Santa Maria - Lisboa - Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CH de Valence
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Cliniche Humanitas Gavazzeni
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
Ospedale Piemonte (IRCCS Bonino Pulejo)
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Centro Hospitalar de Lisboa Norte - Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital de Bellvitge
City
Barcelona
State/Province
Hospitalet De Llobregat
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitari de Girona Doctor Josepj Trueta
City
Girona
ZIP/Postal Code
17190
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
2901
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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