The 4-SITE Field Following Study (4-SITE FF)
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.
ICD and CRT-D Indicated Patients
|Study Design:||Time Perspective: Prospective|
|Official Title:||RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)|
- Appropriate Detection of induced VT [ Time Frame: At Implant or during VT/VF testing up to one month after implant ] [ Designated as safety issue: Yes ]Induced mean VT/VF detection time < 4.5 seconds
- Appropriate induced VT/VF Shock Conversion [ Time Frame: At Implant or during testing within one month after implant ] [ Designated as safety issue: Yes ]Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher
- Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads [ Time Frame: entire duration of the study ] [ Designated as safety issue: Yes ]Mean pacing threshold post implant ≤ 1.5V
- Appropriate Lead Impedances as a measure of lead integrity over 12 month time [ Time Frame: entire study duration ] [ Designated as safety issue: Yes ]
- Shocking lead impedance should be within the range of 20 and 80 OHM
- Pace /sense lead impedance within 200 and 2000 OHM
- Appropriate sensing and absence of artefacts [ Time Frame: entire duration of study ] [ Designated as safety issue: Yes ]Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU
|Study Start Date:||May 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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)