NCT03766919

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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
4 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

December 27, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

October 16, 2018

Last Update Submit

April 15, 2019

Conditions

Ventricular ArrythmiaLeadICDHeart Failure

Keywords

INVICTALeadICDCRT-DMicroPort

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • INVICTA lead pacing threshold

    24 months

  • INVICTA lead impedances

    24 months

  • INVICTA sensing threshold

    24 months

  • Percentage of the shocks that successfully terminate a ventricular arrhythmia episode

    24 months

  • INVICTA lead complication free-rate up to 24 months

    24 months

  • +3 more secondary outcomes

Study Arms (1)

INVICTA lead

EXPERIMENTAL

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

Device: Implant of the INVICTA lead

Interventions

Implant of the INVICTA leadDEVICE

The implant or the attempt to implant an INVICTA lead

INVICTA lead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU

Brest, 29200, France

Location

CHU

Clermont-Ferrand, 63003, France

Location

CH de Valence

Valence, 26000, France

Location

Cliniche Humanitas Gavazzeni

Bergamo, 24125, Italy

Location

Ospedale Piemonte (IRCCS Bonino Pulejo)

Messina, 98124, Italy

Location

Centro Hospitalar de Lisboa Norte - Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital de Bellvitge

Barcelona, Hospitalet de Llobregat, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitari de Girona Doctor Josepj Trueta

Girona, 17190, Spain

Location

Hospital Virgen de la Victoria

Málaga, 2901, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Pedro MARQUES, MD

    Hospital de Santa Maria - Lisboa - Portugal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

December 6, 2018

Study Start

December 27, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2021

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)FR(3)PT(1)IT(2)