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

Ventricular Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856491
• Other study ID #: C1868
• Status: Completed
• Phase: N/A
• Start date: December 16, 2013
• Est. completion date: November 13, 2017

Study information

• Verified date: April 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: November 13, 2017
• Est. primary completion date: November 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Ventricular Fibrillation
• Ventricular Flutter

Intervention

Device:
• RELIANCE 4-FRONT™ Passive Fixation lead implantation
Implantation of transvenous defibrillation lead with passive fixation mechanism.

Locations

Country	Name	City	State
Germany	German Heart Center	Berlin
Israel	Meir Medical Center	Kfar-Saba
Israel	Beilinson Medical Center	Petah-Tikva
Israel	Sheba Medical Center	Tel Hashomer
Italy	Fondazione di Ricerca e Cura 'Giovanni Paolo II	Campobasso
Italy	Ospedale Alessandro Manzoni	Lecco
Italy	Clinica Mediterranea	Naples
Italy	Ospedale Buon Consiglio	Naples
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Osp. Civile S. Maria Delle Grazie	Pozzuoli
Italy	Ospedale San Pietro Fatebenefratelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Germany,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Complication Free Rate	Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant	3 months through 24 months post implant
Other	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 O Defibrillation = 1mV N/A 20—125 O 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
Other	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 O Defibrillation = 1mV N/A 20—125 O 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
Primary	Complication Free Rate	Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.	3-months
Secondary	Complication Free Rate	Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.	3 months through 15 months post implant