Safety and Performance of Invicta ventricular DF4 leads with active fixation.

Recruiting

• Conditions: heart rhythm disorders; cardiac arrhythmias; 10007521

• Registration Number: NL-OMON54422
• Lead Sponsor: Microport CRM B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Indication for an ICD or CRT-D implant, according to ESC guidelines.
2. Scheduled for a de novo implant of an ICD (VR, DR) or CRT-D, manufactured by
Microport CRM, equipped with a DF4-connector.
3. Dated and signed Informed Consent.

Exclusion Criteria

1. Tricuspid valvular disease, or tricuspid valve replacement of any kind.
2. Transient tachy-arhythmias due to reversible causes.
3. Contra-indication to a maximum single dose of 330 ug dexamethasone sodium
phosphate (DSP).
4. Active myocarditis.
5.Previous implant of a pacemaker, ICD or CRT-D device and leads.
6. Enrolled in another study that may confound the results of the Apollo study.
7. Inability to understand the purpose of the study.
8. Under the age of 18.
9. Pre-menopausal women.
10. Drug addiction or drug abuse.
11. Life expectancy less than 1 year.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified