An observational study in ICD and CRT-D Indicated Patients, sponsored by Guidant Corporation. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-05.
Sponsored by Guidant Corporation · Observational
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)
COGNIS 100 HE 4-SITE (CRT-D)
o Model Number: P108 (Quadripolar, IS-1, IS-1)
Guidant Corporation is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study Population: Patients should be selected from the investigator's general population indicated for an ICD or CRT-D Implantation. The investigator has the responsibility of screening all potential patients and selecting those who meet study eligibility criteria.
Study Specific:
General:
Exclusion Criteria:
Study Specific:
General:
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
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Guidant Corporation