The 4-SITE Field Following Study (4-SITE FF)
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Purpose
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.
| Condition |
|---|
|
ICD and CRT-D Indicated Patients |
| Study Type: | Observational |
| 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
| Enrollment: | 430 |
| 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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Study Specific:
- ICD / CRT-D Indication according to normal clinical practice
- Patients receiving:
- a single or dual chamber 4-SITE compatible ICD
- or a 4-SITE compatible CRT-D
- one of the RELIANCE 4-SITE defibrillation leads
- Patients currently implanted with a pacemaker
- upgraded to a 4-SITE compatible ICD or CRT-D (4-SITE header)
- one of the RELIANCE 4-SITE defibrillation leads
General:
- Willing and capable of providing informed consent for
- undergoing a 4-SITE system 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
Exclusion Criteria:
Study Specific:
- ICD and CRT-D Patients scheduled for a device replacement
- CRM Patients who have or who would need an lead adaptor
- All patients who have an active or non-active defibrillation lead other than 4-SITE
General:
- Not willing and not capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation (including VT/VF shock conversion) at an approved clinical investigational centre and at the intervals defined by this protocol
- Patients who were in NYHA Class IV during the last 3 month
- Patients with pre-existing diseases, which may confound study results
- Patients currently requiring dialysis,
- Cancer patients
- Patients with drug and/or alcohol abuse history
- Life expectancy < 12 months (or expected heart transplant within 12 months)
- Patients on a Heart Transplant List
- Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion.
- Enrolled in any other concurrent study
Contacts and Locations More Information
No publications provided
| Responsible Party: | Guidant Corporation |
| ClinicalTrials.gov Identifier: | NCT00920452 History of Changes |
| Other Study ID Numbers: | 4-SITE FF 0209 |
| Study First Received: | June 12, 2009 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Guidant Corporation:
|
implantable cardioverter defibrillator (ICD) defibrillation leads, cardiac resynchronization therapy (CRT) |
ClinicalTrials.gov processed this record on May 23, 2013