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

Suspended

• Conditions: cardiac arrhythmia; heart rhythm disorders; 10007521

• Registration Number: NL-OMON46106
• Lead Sponsor: MicroPort CRM B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-04-11
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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

Primary Outcome Measures

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

Secondary Outcome Measures

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