Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)

NCT04590144 | Completed

• 1 other identifier: LINI01
• Study Type: interventional
• Target: 446
• Locations: 8 countries
• Sites: 45

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)

Conditions

Ventricular Arrythmia; Lead; ICD; Heart Failure

Outcome Measures

Primary Outcomes (2)

• 1.Freedom from INVICTA lead-related complications 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

  90 days

• 2.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 (10)

• 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

• Acute INVICTA lead complications

  30 days

Other Outcomes (3)

• Acute complication rates as a function of the lead position

  < 30 days

• Chronic complication rates as a function of the lead position

  > 30 days

• Electrical performances as a function of the lead position

  24 months

Study Arms (1)

INVICTA lead

EXPERIMENTAL

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

Device: INVICTA lead

Interventions

INVICTA lead DEVICE

The implant or the attempt to implant an INVICTA lead

Also known as: Implant of the INVICTA lead

INVICTA lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient presenting an ICD or CRT-D indication as detailed in the latest ESC guidelines
• Scheduled for a de-novo implant of an ICD (VR, DR) or CRT-D, manufactured by MicroPort CRM and equipped with a DF4 connector
• Signed and dated informed consent

You may not qualify if:

• Tricuspid valvular disease or any type of 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
• Previous implant of pacemaker, ICD or CRT-D device and leads
• Currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study
• Incapacitated subject or under guardianship, inability to understand the purpose of the study, or to meet follow-up visits at the implanting centre as defined in the investigational plan
• Minor subjects
• Pre-menopausal women
• Drug addiction or abuse
• Life expectancy less than 1 year

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (45)

Kepler Universitätsklinikum GmbH

Linz, Austria

Location

CH Annecy

Annecy, France

Location

CHU Brest

Brest, France

Location

CHU Clermont- Ferrand

Clermont-Ferrand, France

Location

CHU Grenoble

Grenoble, France

Location

CHU Lille

Lille, France

Location

Hôpital St Joseph

Marseille, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Tours

Tours, France

Location

RWTH Aachen

Aachen, Germany

Location

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, Germany

Location

Evangelisches Klinikum Bethel

Bielefeld, Germany

Location

Universitäts- Herzzentrum Freiburg -Bad Krozingen

Freiburg im Breisgau, Germany

Location

Hausärztlich- Kardiologisches MVZ "Am Felsenkeller" GmbH

Pirna, Germany

Location

Cliniche Humanitas Gavazzeni

Bergamo, Italy

Location

Ospedale di Desenzano del Garda

Desenzano del Garda, Italy

Location

Ospedale Piemonte (IRCCS Bonino Pulejo)

Messina, Italy

Location

AO di Rilievo Nazionale A. Cardarelli

Napoli, Italy

Location

Univ. degli Studi della Campania L. Vanvitelli

Napoli, Italy

Location

Osp SS Annunziata

Taranto, Italy

Location

AO Univ. S. Maria della Misericordia

Udine, Italy

Location

AULSS 8 Berica - Vicenza

Vicenza, Italy

Location

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

ULS Amadora/Sintra

Amadora, Portugal

Location

ULS de Coimbra

Coimbra, Portugal

Location

ULS do Alto Ave

Creixomil, Portugal

Location

ULS Alentejo Central

Evora, Portugal

Location

Hospital Santa Maria

Lisbon, Portugal

Location

ULS de Sao Jose - Hospital Santa Marta

Lisbon, Portugal

Location

ULS Santo Antonio

Porto, Portugal

Location

ULS Gaia/Espinho

Vila Nova de Gaia, Portugal

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain, Spain

Location

Hospital General de Alicante

Alicante, Spain

Location

Hospital Josep Trueta,

Girona, Spain

Location

Hospital Virgen de las Nieves

Granda, Spain

Location

Hospital Universitario de Gran Canaria

Las Palmas, Spain

Location

Hospital Clinico de Madrid

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Barnet Hospital, Royal Free Trust

Barnet, United Kingdom

Location

Queen Elizabeth

Birmingham, United Kingdom

Location

Great Western Hospital

Swindon, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular 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

Model Details: INVICTA lead

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: June 4, 2021
• Primary Completion: March 16, 2022
• Study Completion: December 23, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

AU (1); FR (8); PT (8); GB (3); ES (10); DE (5); IT (8); NL (2)