An interventional study of INVICTA lead in Ventricular Arrythmia, Lead and ICD, sponsored by MicroPort CRM. Completed at 45 sites in 8 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by MicroPort CRM (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment
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)
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
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 446 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →MicroPort CRM is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
First submitted after MicroPort CRM became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead
Device: INVICTA lead
The implant or the attempt to implant an INVICTA lead
Also known as: Implant of the INVICTA lead
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
Time frame: 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
Time frame: 3 months
INVICTA lead pacing threshold
RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
Time frame: 24 months
INVICTA lead impedances
RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
Time frame: 24 months
INVICTA sensing threshold
RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D
Time frame: 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
Time frame: 24 months
Acute INVICTA lead complications
Assessment of Acute INVICTA lead complications
Time frame: 30 days
Chronic INVICTA lead complications
Assessment of Chronic INVICTA lead complications
Time frame: > 30 days
Daily INVICTA autothreshold values (V)
Assessment of Daily INVICTA autothreshold values (V)
Time frame: 1 month
.INVICTA lead handling assessment
Summary of the investigators' opinion about INVICTA handling at implant
Time frame: At implant (day 0)
INVICTA lead implant success rate
% of enrolled patients successfully implanted with an INVICTA lead
Time frame: At implant (day 0)
Serious Adverse Events up to 24 months
Report of SAEs occurred up to 24 months post-implantation
Time frame: 24 months
Acute complication rates as a function of the lead position
Acute complication rates as a function of the lead position (apical vs septal)
Time frame: < 30 days
Chronic complication rates as a function of the lead position
Chronic complication rates as a function of the lead position (apical vs septal
Time frame: > 30 days
Electrical performances as a function of the lead position
Electrical performances as a function of the lead position (apical vs septal)
Time frame: 24 months
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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