CompletedNot Applicable

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

Austria, France446 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 range18 Years

SexALL

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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
✕. Minor subjects

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