Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
NCT ID: NCT04590144
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
446 participants
INTERVENTIONAL
2021-06-04
2024-12-23
Brief Summary
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Detailed Description
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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)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 total number of 445 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INVICTA lead
All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead
INVICTA lead
The implant or the attempt to implant an INVICTA lead
Interventions
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INVICTA lead
The implant or the attempt to implant an INVICTA lead
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled for a de-novo implant of an ICD (VR, DR) or CRT-D, manufactured by MicroPort CRM and equipped with a DF4 connector
3. Signed and dated informed consent
Exclusion Criteria
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. Previous implant of pacemaker, ICD or CRT-D device and leads
6. Currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study
7. 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
8. Minor subjects
9. Pre-menopausal women
10. Drug addiction or abuse
11. Life expectancy less than 1 year
18 Years
ALL
Yes
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Principal Investigators
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Pedro Marques, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Santa Maria - Lisboa - Portugal
Locations
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Kepler Universitätsklinikum GmbH
Linz, , Austria
CH Annecy
Annecy, , France
CHU Brest
Brest, , France
CHU Clermont- Ferrand
Clermont-Ferrand, , France
CHU Grenoble
Grenoble, , France
CHU Lille
Lille, , France
Hôpital St Joseph
Marseille, , France
CHU Strasbourg
Strasbourg, , France
CHU Tours
Tours, , France
RWTH Aachen
Aachen, , Germany
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, , Germany
Evangelisches Klinikum Bethel
Bielefeld, , Germany
Universitäts- Herzzentrum Freiburg -Bad Krozingen
Freiburg im Breisgau, , Germany
Hausärztlich- Kardiologisches MVZ "Am Felsenkeller" GmbH
Pirna, , Germany
Cliniche Humanitas Gavazzeni
Bergamo, , Italy
Ospedale di Desenzano del Garda
Desenzano del Garda, , Italy
Ospedale Piemonte (IRCCS Bonino Pulejo)
Messina, , Italy
AO di Rilievo Nazionale A. Cardarelli
Napoli, , Italy
Univ. degli Studi della Campania L. Vanvitelli
Napoli, , Italy
Osp SS Annunziata
Taranto, , Italy
AO Univ. S. Maria della Misericordia
Udine, , Italy
AULSS 8 Berica - Vicenza
Vicenza, , Italy
Elisabeth Tweesteden Ziekenhuis
Tilburg, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
ULS Amadora/Sintra
Amadora, , Portugal
ULS de Coimbra
Coimbra, , Portugal
ULS do Alto Ave
Creixomil, , Portugal
ULS Alentejo Central
Evora, , Portugal
Hospital Santa Maria
Lisbon, , Portugal
ULS de Sao Jose - Hospital Santa Marta
Lisbon, , Portugal
ULS Santo Antonio
Porto, , Portugal
ULS Gaia/Espinho
Vila Nova de Gaia, , Portugal
Hospital Clínico Universitario de Valencia
Valencia, Spain, Spain
Hospital General de Alicante
Alicante, , Spain
Hospital Josep Trueta,
Girona, , Spain
Hospital Virgen de las Nieves
Granda, , Spain
Hospital Universitario de Gran Canaria
Las Palmas, , Spain
Hospital Clinico de Madrid
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Barnet Hospital, Royal Free Trust
Barnet, , United Kingdom
Queen Elizabeth
Birmingham, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Countries
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Other Identifiers
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LINI01
Identifier Type: -
Identifier Source: org_study_id
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