RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 167
- Locations
- 11
- Primary Endpoint
- Complication Free Rate
Study Overview
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 chronic safety, performance and effectiveness of the RELIANCE 4-FRONT passive fixation defibrillation leads.
A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.
Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
RELIANCE 4-FRONT™ Passive Fixation
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
Intervention: RELIANCE 4-FRONT™ Passive Fixation lead implantation (Device)
Outcomes
Primary Outcomes
Complication Free Rate
Time Frame: 3-months
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Secondary Outcomes
- Complication Free Rate(3 months through 15 months post implant)