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

Not Applicable

Completed

• Conditions: Ventricular Fibrillation; Tachycardia; Ventricular Flutter
• Interventions: Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation

• Registration Number: NCT01856491
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-17
• Study Start: 2013-12-16
• Primary Completion: 2015-11-02
• Results First Submitted: 2017-07-27
• Study Completion: 2017-11-13
• Results First Submitted QC: 2017-11-16
• Results First Posted: 2017-11-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RELIANCE 4-FRONT™ Passive Fixation	RELIANCE 4-FRONT™ Passive Fixation lead implantation	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead

Primary Outcome Measures

Name	Time	Method
Complication Free Rate	3-months	Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Secondary Outcome Measures

Name	Time	Method
Complication Free Rate	3 months through 15 months post implant	Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.

Trial Locations

Locations (11)

German Heart Center; 🇩🇪 Berlin, Germany

Meir Medical Center; 🇮🇱 Kfar-Saba, Israel

Beilinson Medical Center; 🇮🇱 Petah-Tikva, Israel

Ospedale Buon Consiglio; 🇮🇹 Naples, Italy

Fondazione di Ricerca e Cura 'Giovanni Paolo II; 🇮🇹 Campobasso, Italy

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Ospedale Alessandro Manzoni; 🇮🇹 Lecco, Italy

Clinica Mediterranea; 🇮🇹 Naples, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Ospedale San Pietro Fatebenefratelli; 🇮🇹 Rome, Italy

Osp. Civile S. Maria Delle Grazie; 🇮🇹 Pozzuoli, Italy