Safety and Electrical Performance Evaluation of Invicta Leads Models Equipped with DF4 Connector.

Safety and Electrical Performance Evaluation of Invicta Leads Models Equipped with DF4 Connector. - FRIENDS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46106

Enrollment

Registered

2018-11-22

Start date

2018-11-01

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac arrhythmia heart rhythm disorders

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Indication for ICD or CRT/D implant (defibrillator) according to ESC guidelines.

Exclusion criteria

Exclusion criteria: Tricuspid valvular disease or mechanical heart valve. Active myocarditis. Pregnant, or not taking/using contraceptives when of a fertile age.

Design outcomes

Primary

Measure	Time frame
Lead safety after 3 months: absence of any lead-related complications. Electrical performance after 3 months: stable stimulation thresholds in the right ventricle (expected values: 1 Volt +/- 0,5 Volt and a pulse duration of 0,5 ms.	—

Secondary

Measure	Time frame
Document electrical performance of the right ventricular lead: sensing thershold in mV, impedance in Ohm, stimulation threshold in Volt x ms. Document good detection of VT and VF, as well as adequate delivery of therapy (anti-tachy pacing or defibrillation shock). Safety of the right ventricular lead. Handling assessment of the right ventricular lead. Successful implant percentage of the right ventricular lead.	—

Measure

Time frame

Document electrical performance of the right ventricular lead: sensing thershold in mV, impedance in Ohm, stimulation threshold in Volt x ms. Document good detection of VT and VF, as well as adequate delivery of therapy (anti-tachy pacing or defibrillation shock). Safety of the right ventricular lead. Handling assessment of the right ventricular lead. Successful implant percentage of the right ventricular lead.

—

Countries

Netherlands

Outcome results