N/A
Completed N=167
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
Tachycardia · ventricular fibrillation · Ventricular Flutter
Source: ClinicalTrials.gov NCT01856491 ↗
Enrolled (actual)
167
Serious AEs
50.3%
Results posted
Nov 2017
Primary outcomePrimary: Complication Free Rate — 97.5 percentage of patients without event
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication Free Rate |
99.4 | — |
| SECONDARY Complication Free Rate |
99.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01856491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.