RELIANCE 4-FRONT™ Active Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tachycardia
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 167
- Locations
- 15
- Primary Endpoint
- Complication Free Rate
- Status
- Completed
- Last Updated
- 8 years ago
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™ Active Fixation Defibrillation Leads.
Detailed Description
The RELIANCE 4-FRONT 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 active fixation defibrillation leads. A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint. Up to 20 Investigational centers located in Europe and Asia Pacific. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant. Lead-related complications associated with the RELIANCE 4-FRONT active fixation lead will count toward this endpoint. Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant. Lead-related complications associated with the RELIANCE 4-FRONT active fixation lead will count toward this endpoint. * Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant * Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant * Sensed Amplitude at 3 Months Post-Implant * Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the RELIANCE 4-FRONT active fixation lead. Clinic visits will occur at: * Enrollment Visit (no later than 30 days prior to implant procedure) * Implant Procedure (Day 0; all future follow ups based on this date) * Pre-Discharge Clinic Visit (3 - 72 hours post-implant) * One Month Clinic Visit (30±7 days) * 3 Month Clinic Visit (91 ± 21 days) * 6 Month Clinic Visit (180 ± 30 days) * 12 Month Clinic Visit (365 ± 45 days) * 18 Month Clinic Visit (545± 45 days) * 24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all subjects have completed the 24 Month follow-up and study completion is anticipated in 2015. Primary endpoint completion is anticipated after all subjects have completed the 3 Month follow-up visit. All study required visits will be completed during clinic visits. Hypotheses testing in the RELIANCE 4-FRONT PMCF Study will use standard statistical methodology as specified more in detail in the protocol.
Investigators
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 Active 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
Outcomes
Primary Outcomes
Complication Free Rate
Time Frame: 3-months follow-up
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)