Status:
COMPLETED
The 4-SITE Field Following Study (4-SITE FF)
Lead Sponsor:
Guidant Corporation
Conditions:
ICD and CRT-D Indicated Patients
Eligibility:
All Genders
18+ years
Brief Summary
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 defib...
Detailed Description
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00920452
Start Date
May 1 2009
End Date
January 1 2011
Last Update
December 5 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany, D - 32545