Status:
COMPLETED
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
Detailed Description
The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the...
Eligibility Criteria
Inclusion
- Willing and capable of providing informed consent
- Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography
- Subjects planned to be implanted with the RELIANCE 4-FRONT Passive Fixation Lead
- Willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
- Age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion
- Known or suspected sensitivity to Dexamethasone Acetate (DXA)
- Mechanical tricuspid heart valve
- Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);
- RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);
- Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations
- Currently on the active heart transplant list
- Documented life expectancy of less than 12 months
- Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion)
- Currently requiring chronic dialysis
Key Trial Info
Start Date :
December 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2017
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT01856491
Start Date
December 16 2013
End Date
November 13 2017
Last Update
April 30 2019
Active Locations (11)
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1
German Heart Center
Berlin, Germany, 13353
2
Meir Medical Center
Kfar Saba, Israel, 44281
3
Beilinson Medical Center
Petah Tikva, Israel, 49100
4
Sheba Medical Center
Tel Litwinsky, Israel, 52621