The purpose of this study is to evaluate and document appropriate clinical performance of the new RELIANCE Quadripolar (4-SITE) defibrillation lead and the 4-SITE Header / Lead interface when connected to the TELIGEN 100 HE 4-SITE (VR or DR)…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate appropriate performance of
the RELIANCE 4-SITE defibrillation lead and of the new 4-SITE Header / Lead
interface by demonstrating - appropriate detection and shock conversion of
induced Ventricular tachyarrhythmia*s (VT/VF)
-appropriate pacing thresholds, shock and pacing lead Impedances at follow-up
as a measure of lead integrity over 12 month time, and - Appropriate sensing
and absence of artefacts / non-sustained / sustained episodes resulting from
transient potentials (artefacts) originating from incomplete lead / header
contact.
Secondary outcome
The secondary objectives are to document Implant Experience by collecting and
analyzing information regarding 4-Site system handling, and to answer clinical
questions by performing different types of retrospective analysis of study
data.
Background summary
The purpose of the study is to test a new lead: de RELIANCE quadripolar
(4-SITE) defibrillation lead implanted together with an implantable 4-SITE
cardioverter defibrillator (*4-SITE ICD*) from Boston Scientific: the TELIGEN
100 HE 4-SITE ICD (VR or DR) of the COGNIS 100 HE 4-SITE CRT-D.
The 4-SITE lead is special because it only has one pin to attach it to the
device rather than the 3 pins used with previous style leads. This one pin
contains all the functions from the previous lead type.
Study objective
The purpose of this study is to evaluate and document appropriate clinical
performance of the new RELIANCE Quadripolar (4-SITE) defibrillation lead and
the 4-SITE Header / Lead interface when connected to the TELIGEN 100 HE 4-SITE
(VR or DR) implantable cardioverter defibrillator ICD, or the COGNIS 100 HE
4-SITE cardiac resynchronization therapy CRT-D.
Study design
This is a Prospective, multi-centre, field following study with data collected
from a maximum of 450 patients at up to 50 study centres worldwide.
Patients enrolled for the study will be followed for a period of 12 month after
implant: at implant, pre-discharge (optional), 1, 3, 6, 9 and 12-months. It is
estimated that the patient enrollment will be completed in approximately 9
months. The study is expected to start enrollment in Q2 of 2009. The total
duration of the study is expected to be approximately 21 month.
Study burden and risks
Burden : patients require an additional visit at month 1, 3 and 9 months.
Risk : the risks related to study participation are the same as when the
patient would not participate to the study.
Lambroekstraat 5D
1831 Diegem
BE
Lambroekstraat 5D
1831 Diegem
BE
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27592.058.09 |