Ventricular ArrythmiaAPOLLONCT04590144
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
A study testing INVICTA lead in people with Ventricular Arrythmia and Lead, run by MicroPort CRM at 45 sites in 8 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventricular Arrythmia, Lead, ICD
- What is being tested?
- INVICTA lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 45 sitesin 8 countries
- Study dates
- 4 Jun 2021to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
45 sites in 8 countries.
45 sites in 8 countries
Spain10 sites
Hospital General de Alicante
Alicante
Hospital Josep Trueta,
Girona
Hospital Virgen de las Nieves
Granda
Hospital Universitario de Gran Canaria
Las Palmas
Hospital Clinico de Madrid
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital General Universitario de Valencia
Valencia
Hospital Universitario y Politécnico La Fe
Valencia
France8 sites
CH Annecy
Annecy
CHU Brest
Brest
CHU Clermont- Ferrand
Clermont-Ferrand
CHU Grenoble
Grenoble
CHU Lille
Lille
Hôpital St Joseph
Marseille
CHU Strasbourg
Strasbourg
CHU Tours
Tours
Italy8 sites
Cliniche Humanitas Gavazzeni
Bergamo
Ospedale di Desenzano del Garda
Desenzano del Garda
Ospedale Piemonte (IRCCS Bonino Pulejo)
Messina
AO di Rilievo Nazionale A. Cardarelli
Naples
Univ. degli Studi della Campania L. Vanvitelli
Naples
Osp SS Annunziata
Taranto
AO Univ. S. Maria della Misericordia
Udine
AULSS 8 Berica - Vicenza
Vicenza
Portugal8 sites
ULS Amadora/Sintra
Amadora
ULS de Coimbra
Coimbra
ULS do Alto Ave
Creixomil
ULS Alentejo Central
Evora
Hospital Santa Maria
Lisbon
ULS de Sao Jose - Hospital Santa Marta
Lisbon
ULS Santo Antonio
Porto
ULS Gaia/Espinho
Vila Nova de Gaia
Germany5 sites
RWTH Aachen
Aachen
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen
Evangelisches Klinikum Bethel
Bielefeld
Universitäts- Herzzentrum Freiburg -Bad Krozingen
Freiburg im Breisgau
Hausärztlich- Kardiologisches MVZ "Am Felsenkeller" GmbH
Pirna
United Kingdom3 sites
Barnet Hospital, Royal Free Trust
Barnet
Queen Elizabeth
Birmingham
Great Western Hospital
Swindon
Netherlands2 sites
Elisabeth Tweesteden Ziekenhuis
Tilburg
Isala Klinieken
Zwolle
About this study
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)
Read the detailed description
APOLLO 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)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
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Being tested
- INVICTA lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVICTA leadDevice
Also called Implant of the INVICTA lead
The implant or the attempt to implant an INVICTA lead
| Study group | Role | What they receive |
|---|---|---|
| INVICTA lead | Experimental | All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead Receives: Device: INVICTA lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (10)
INVICTA lead pacing threshold
RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
Measured: 24 months
INVICTA lead impedances
RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
Measured: 24 months
INVICTA sensing threshold
RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D
Measured: 24 months
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
Measured: 24 months
Acute INVICTA lead complications
Assessment of Acute INVICTA lead complications
Measured: 30 days
Chronic INVICTA lead complications
Assessment of Chronic INVICTA lead complications
Measured: > 30 days
Daily INVICTA autothreshold values (V)
Assessment of Daily INVICTA autothreshold values (V)
Measured: 1 month
.INVICTA lead handling assessment
Summary of the investigators' opinion about INVICTA handling at implant
Measured: At implant (day 0)
INVICTA lead implant success rate
% of enrolled patients successfully implanted with an INVICTA lead
Measured: At implant (day 0)
Serious Adverse Events up to 24 months
Report of SAEs occurred up to 24 months post-implantation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start4 Jun 2021
- Primary completion16 Mar 2022
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- INVICTA lead
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Marques, MD, Principal investigator, Hospital de Santa Maria - Lisboa - Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590144
- Sponsor's protocol ID
- LINI01
- Acronym
- APOLLO
- Status last verified
- Jul 2025
- First submitted
- 9 Oct 2020
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
- ClinicalTrials.gov ID
- NCT04590144
- Acronym / sponsor ID
- APOLLO / LINI01
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
APOLLO 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)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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- INVICTA lead
| Arm | Type | Receives |
|---|---|---|
| INVICTA lead | Experimental | Device: INVICTA leadAll patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INVICTA leadAlso: Implant of the INVICTA leadThe implant or the attempt to implant an INVICTA lead | Device | INVICTA lead |
Primary outcome
1.Freedom from INVICTA lead-related complications 1.Freedom from INVICTA lead-related complications [Time Frame: 90 days
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
10 secondary outcomes
INVICTA lead pacing threshold
Time frame: 24 months
INVICTA lead impedances
Time frame: 24 months
INVICTA sensing threshold
Time frame: 24 months
Percentage of the shocks that successfully terminate a ventricular arrhythmia episode
Time frame: 24 months
Acute INVICTA lead complications
Time frame: 30 days
Chronic INVICTA lead complications
Time frame: > 30 days
Daily INVICTA autothreshold values (V)
Time frame: 1 month
.INVICTA lead handling assessment
Time frame: At implant (day 0)
INVICTA lead implant success rate
Time frame: At implant (day 0)
Serious Adverse Events up to 24 months
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
Related trials for Ventricular Arrythmia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
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EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Marques, MD principal investigator
Hospital de Santa Maria - Lisboa - Portugal
45 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVICTA lead in people with Ventricular Arrythmia and Lead, run by MicroPort CRM at 45 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Spain, France, Italy, Portugal, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Freedom from INVICTA lead-related complications 1.Freedom from INVICTA lead-related complications [Time Frame: 90 days (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.