Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead

RELIANCE 4-FRONT™ Passive 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™ Passive Fixation Defibrillation Leads.

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Tachycardia; Ventricular Flutter
• Intervention / Treatment: Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation

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.

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.

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

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • German Heart Center
• Israel
  • Kfar-Saba, Israel, 44281
    • Meir Medical Center
  • Petah-Tikva, Israel, 49100
    • Beilinson medical center
  • Tel Hashomer, Israel, 52621
    • Sheba Medical Center
• Italy
  • Campobasso, Italy
    • Fondazione di Ricerca e Cura 'Giovanni Paolo II
  • Lecco, Italy, 23900
    • Ospedale Alessandro Manzoni
  • Naples, Italy, 80121
    • Clinica Mediterranea
  • Naples, Italy, 80123
    • Ospedale Buon Consiglio
  • Pisa, Italy, 56127
    • Azienda Ospedaliero Universitaria Pisana
  • Pozzuoli, Italy, 80078
    • Osp. Civile S. Maria Delle Grazie
  • Rome, Italy, 00189
    • Ospedale San Pietro Fatebenefratelli

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RELIANCE 4-FRONT™ Passive Fixation; Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead	Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation; Implantation of transvenous defibrillation lead with passive fixation mechanism.

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

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
Pacing Threshold at 0.5 ms Pulse Width	Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.	3 Months Post-Implant
Complication Free Rate	Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant	3 months through 24 months post implant
Sensed Amplitude	Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.	3 Months Post-Implant
Pacing Impedance	Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.	3 Months Post-Implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2013
• Primary Completion (Actual): November 2, 2015
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Implantable Cardioverter Defibrillator (ICD); RELIANCE 4-FRONT; Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Ventricular Flutter
• Other Study ID Numbers: C1868

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