Cognis and Teligen 100 HE & Reliance Quadripolar Defibrillation Lead (4-Site) Field Following

Phase 4

• Conditions: Ventricular Tachyarrhythmia's - cardiac rythm disorder; 10007521

• Registration Number: NL-OMON32376
• Lead Sponsor: Boston Scientific

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Inclusion Criteria TELIGEN and COGNIS 100 HE:
• ICD Indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
• CRT-D Indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
• Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
• Geographically stable patients who are available for follow-up at a study centre.
• Age 18 or above, or of legal age to give informed consent specific to national law
Reverse Mode Switch Sub-Study:
• Meet general inclusion/exclusion criteria for COGENT-4 study
• Implanted with TELIGEN 100 HE DR

Exclusion Criteria

Exclusion Criteria TELIGEN and COGNIS 100 HE
• Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
• Patients currently requiring dialysis
• Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
• Enrolled in any concurrent study
• Patients implanted with the following leads which will not be abandoned:
- Atrial or right ventricular unipolar leads
- Patch defibrillation leads
- Non-compatible defibrillation leads (e.g. 5/6mm)
Reverse Mode Switch Sub-Study:
• Documented permanent/Complete AV block
• Documented permanent atrial fibrillation (AF)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The Device Specific Objectives of this study are to evaluate performance of all<br /><br>TELIGEN and COGNIS 100 HE devices as shown by documenting appropriate detection<br /><br>and shock conversion of induced ventricular tachyarrhythmia*s (VT/VF) at<br /><br>implant and/or pre-discharge. The RMS-Specific Objectives of this study are to<br /><br>evaluate appropriate performance of the Reverse Mode Switch (RMS) feature by<br /><br>documenting a 1-month RMS related Adverse-Event-Free-rate in TELIGEN 100 HE DR<br /><br>patients with the feature ON. And also to evaluate appropriate performance of<br /><br>the Reverse Mode Switch (RMS) feature by documenting a reduction in right<br /><br>ventricular pacing (Vp) with the feature ON versus OFF between the 1-month and<br /><br>3-month visit. The Lead- Specific Objective of this study is to evaluate<br /><br>appropriate performance of the RELIANCE 4-SITE defibrillation lead by<br /><br>demonstrating appropriate pacing thresholds at follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the performance of the Quick Convert ATP feature during normal<br /><br>clinical operation, to collect the number and appropriate function of Reverse<br /><br>Mode Switches during normal clinical operation, to collect and report<br /><br>percentage of BiV pacing in COGNIS 100 HE patients, to collect and report<br /><br>Respiration Rate Trend data, if available and to collect and report all adverse<br /><br>events including specifically all 4-SITE lead-related Adverse Events.</p><br>