Ventricular Tachyarrhythmia's - cardiac rythm disorder
Conditions
Interventions
None listed
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Device Specific Objectives of this study are to evaluate performance of all TELIGEN and COGNIS 100 HE devices as shown by documenting appropriate detection and shock conversion of induced ventricular tachyarrhythmia*s (VT/VF) at implant and/or pre-discharge. The RMS-Specific Objectives of this study are to evaluate appropriate performance of the Reverse Mode Switch (RMS) feature by documenting a 1-month RMS related Adverse-Event-Free-rate in TELIGEN 100 HE DR patients with the feature ON. And also to evaluate appropriate performance of the Reverse Mode Switch (RMS) feature by documenting a reduction in right ventricular pacing (Vp) with the feature ON versus OFF between the 1-month and 3-month visit. The Lead- Specific Objective of this study is to evaluate appropriate performance of the RELIANCE 4-SITE defibrillation lead by demonstrating appropriate pacing thresholds at follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the performance of the Quick Convert ATP feature during normal clinical operation, to collect the number and appropriate function of Reverse Mode Switches during normal clinical operation, to collect and report percentage of BiV pacing in COGNIS 100 HE patients, to collect and report Respiration Rate Trend data, if available and to collect and report all adverse events including specifically all 4-SITE lead-related Adverse Events. | — |
Countries
Netherlands
Outcome results
None listed