The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE Quadripolar (4-SITE) defibrillation leads. Appropriate clinical performance of system components of the 4-SITE systems other than the new 4-SITE header / lead interface has been evaluated and documented already in the previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field Following Study. Data collected may be used to support international regulatory submissions including the FDA and the Japanese Ministry of Health, Labour and Welfare.
The following devices will be used (all are CE-marked): * TELIGEN 100 HE 4-SITE (Single and Dual Chamber ICD) * Model Number: F103 (Quadripolar, VR); * Model Number: F111 (Quadripolar, IS-1, DR) * COGNIS 100 HE 4-SITE (CRT-D) o Model Number: P108 (Quadripolar, IS-1, IS-1) * RELIANCE 4-SITE leads (12 different model numbers in total as shown in the table below)
Study Type
OBSERVATIONAL
Enrollment
430
Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany
Appropriate Detection of induced VT
Induced mean VT/VF detection time \< 4.5 seconds
Time frame: At Implant or during VT/VF testing up to one month after implant
Appropriate induced VT/VF Shock Conversion
Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher
Time frame: At Implant or during testing within one month after implant
Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads
Mean pacing threshold post implant ≤ 1.5V
Time frame: entire duration of the study
Appropriate Lead Impedances as a measure of lead integrity over 12 month time
* Shocking lead impedance should be within the range of 20 and 80 OHM * Pace /sense lead impedance within 200 and 2000 OHM
Time frame: entire study duration
Appropriate sensing and absence of artefacts
Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU
Time frame: entire duration of study
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