Overview

This trial is active, not recruiting.

Conditions tachycardia, ventricular fibrillation, ventricular flutter
Treatment reliance 4-front™ passive fixation lead implantation
Sponsor Boston Scientific Corporation
Start date December 2013
End date December 2016
Trial size 167 participants
Trial identifier NCT01856491, C1868

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
reliance 4-front™ passive fixation lead implantation
Implantation of transvenous defibrillation lead with passive fixation mechanism.

Primary Outcomes

Measure
Complication free rate
time frame: 3-months

Secondary Outcomes

Measure
Complication free rate
time frame: 3 months through 15 months post implant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
Principal investigator Maria Grazia Bongiorni, MD
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. 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 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 passive 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 passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.