Ventricular ArrythmiaFRIENDSNCT03766919
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
A study testing Implant of the INVICTA lead in people with Ventricular Arrythmia and Lead, run by MicroPort CRM at 10 sites in 4 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) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia, Lead, ICD
- What is being tested?
- Implant of the INVICTA lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 27 Dec 2018to Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Spain4 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital de Bellvitge
Barcelona, Hospitalet de Llobregat
Hospital Universitari de Girona Doctor Josepj Trueta
Girona, 17190
Hospital Virgen de la Victoria
Málaga, 2901
France3 sites
CHU
Brest, 29200
CHU
Clermont-Ferrand, 63003
CH de Valence
Valence, 26000
Italy2 sites
Cliniche Humanitas Gavazzeni
Bergamo, 24125
Ospedale Piemonte (IRCCS Bonino Pulejo)
Messina, 98124
Portugal1 site
Centro Hospitalar de Lisboa Norte - Santa Maria
Lisbon, 1649-035
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) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).
Read the detailed description
FRIENDS 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) and passive fixation, either single coil (model 1CT) or dual coil (model 2CT) 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 maximum number of 224 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
- Implant of the INVICTA lead
- Keywords
- INVICTA, Lead, ICD, CRT-D, MicroPort
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of the INVICTA leadDevice
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: Implant of the INVICTA lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Secondary outcomes (8)
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
INVICTA lead complication free-rate up to 24 months
Report of INVICTA lead complication free-rate (complication defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention) up to 24 months post-implantation
Measured: 24 months
INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months
Report of INVICTA lead-related SADEs and device deficiencies occurred up to 24 months post-implantation
Measured: 24 months
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start27 Dec 2018
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT03766919
- Sponsor's protocol ID
- LNC001
- Other IDs
- CIV-PT-18-08-025366
- Acronym
- FRIENDS
- Status last verified
- Apr 2019
- First submitted
- 16 Oct 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
- ClinicalTrials.gov ID
- NCT03766919
- Acronym / sponsor ID
- FRIENDS / LNC001
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Keywords
- INVICTA, Lead, ICD, CRT-D, MicroPort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 6 Dec 2018 (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) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).
Detailed description
FRIENDS 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) and passive fixation, either single coil (model 1CT) or dual coil (model 2CT) 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 maximum number of 224 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
| Arm | Type | Receives |
|---|---|---|
| INVICTA lead | Experimental | Device: Implant of the 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
- Not 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 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Implant of the INVICTA leadThe implant or the attempt to implant an INVICTA lead | Device | INVICTA lead |
Primary outcome
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.
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
8 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
INVICTA lead complication free-rate up to 24 months
Time frame: 24 months
INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months
Time frame: 24 months
INVICTA lead handling assessment
Time frame: At Implant (Day 0)
INVICTA lead implant success rate
Time frame: At Implant (Day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Ventricular Arrythmia
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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
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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
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant of the INVICTA lead in people with Ventricular Arrythmia and Lead, run by MicroPort CRM at 10 sites in 4 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 9 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, France, Italy, Portugal. 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?
Results are not available in the source record.
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?
Freedom from INVICTA lead-related complications (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 16 Apr 2019.