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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
Sponsor:
Information provided by (Responsible Party):
LivaNova

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).

Condition or disease Intervention/treatment Phase
Ventricular Arrythmia Lead ICD Heart Failure Device: Implant of the INVICTA lead Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 224 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. INVICTA lead impedances [ Time Frame: 24 months ]
    RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D

  3. INVICTA sensing threshold [ Time Frame: 24 months ]
    RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D

  4. 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.

  5. 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

  6. 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

  7. INVICTA lead handling assessment [ Time Frame: At Implant (Day 0) ]
    Summary of the investigators' opinion about INVICTA handling at implant

  8. INVICTA lead implant success rate [ Time Frame: At Implant (Day 0) ]
    % of enrolled patients successfully implanted with an INVICTA lead



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Alberto BORRI BRUNETTO +39 161 487211 alberto.borri.brunetto@crm.microport.com

Sponsors and Collaborators
LivaNova
Investigators
Principal Investigator: Pedro MARQUES, MD Hospital de Santa Maria - Lisboa - Portugal

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT03766919     History of Changes
Other Study ID Numbers: LNC001
CIV-PT-18-08-025366 ( Other Identifier: INFARMED (Eudamed code) )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by LivaNova:
INVICTA
Lead
ICD
CRT-D
MicroPort

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases