CompletedNot Applicable

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

Austria, France, Germany446 participantsStarted 2021-06-04

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1.Freedom from INVICTA lead-related complications 1.Freedom from INVICTA lead-related complications [Time Frame: 90 days

Timeframe: 90 days

2.INVICTA lead electrical performance at 3 months

Timeframe: 3 months

Trial details

NCT IDNCT04590144

SponsorMicroPort CRM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-16

View on ClinicalTrials.gov More Ventricular Arrythmia trials