Safety and Performance Study of the Reliance 4-Front Lead

RELIANCE 4-FRONT™ Active Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study

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.

Study Overview

• Status: Completed
• Conditions: Tachycardia
• Intervention / Treatment: Device: Reliance 4-Front lead implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • St. Pölten, Austria, 3100
    • Landesklinikum St. Poelten
• China
  • Hong Kong, China
    • Queen Mary Hospital
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospitals
• France
  • Massy, France, 91300
    • Institut Cardiovasculaire - Paris Sud
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
• Israel
  • Ashkelon, Israel, 78306
    • Barzilai Medical Center
  • Tel Hashomer, Israel, 52621
    • Sheba Medical Center
• Italy
  • Lecco, Italy, 23900
    • Ospedale Alessandro Manzoni
  • Pisa, Italy, 56127
    • Azienda Ospedaliero Universitaria Pisana
• Portugal
  • Carnaxide, Portugal, 2790-134
    • Hospital de Santa Cruz
• Spain
  • Malaga, Spain, 29019
    • Hospital Universitario Virgen De La Victoria
• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska hospital
• United Kingdom
  • Bristol, United Kingdom, BS2 8HW
    • Bristol Royal Infirmary
  • Clydebank, United Kingdom, G81 4HX
    • Golden Jubilee National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Reliance 4-Front; Single arm, all patients will be implanted with the Reliance 4-Front lead	Device: Reliance 4-Front lead implantation; The patients selected for participation should be from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Free Rate	Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.	3-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Free Rate	Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.	3 months through 15 months post implant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Free Rate	Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant	3 Months through 24 Months Post-Implant
Pacing Threshold	Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant	3-months post-implant
Sensed Amplitude	Sensed Amplitude at 3 Months Post-Implant	3 Months Post-Implant
Pacing Impedance	Pacing Impedance at 3 Months Post-Implant	3 Months Post-Implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (ESTIMATE): January 21, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Implantable Cardioverter Defibrillator (ICD); Cardiac Resynchronization Therapy - Defibrillator (CRT-D); Reliance
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: BSC-CDM00052753; C1830 (OTHER_GRANT: C1830)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes