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

NCT01856491 | Completed Results FDA Device

• 1 other identifier: C1868
• Study Type: interventional
• Target: 167
• Locations: 3 countries
• Sites: 11

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.

Conditions

Tachycardia; Ventricular Fibrillation; Ventricular Flutter

Keywords

RELIANCE 4-FRONT; Implantable Cardioverter Defibrillator (ICD); Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

Outcome Measures

Primary Outcomes (1)

• Complication Free Rate

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

  3-months

Secondary Outcomes (1)

• Complication Free Rate

  3 months through 15 months post implant

Other Outcomes (4)

• Pacing Threshold at 0.5 ms Pulse Width

  3 Months Post-Implant

• Complication Free Rate

  3 months through 24 months post implant

• Sensed Amplitude

  3 Months Post-Implant

Study Arms (1)

RELIANCE 4-FRONT™ Passive Fixation

OTHER

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

Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation

Interventions

RELIANCE 4-FRONT™ Passive Fixation lead implantation DEVICE

Implantation of transvenous defibrillation lead with passive fixation mechanism.

RELIANCE 4-FRONT™ Passive Fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (11)

German Heart Center

Berlin, 13353, Germany

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Beilinson Medical Center

Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Fondazione di Ricerca e Cura 'Giovanni Paolo II

Campobasso, Italy

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

Clinica Mediterranea

Naples, 80121, Italy

Location

Ospedale Buon Consiglio

Naples, 80123, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56127, Italy

Location

Osp. Civile S. Maria Delle Grazie

Pozzuoli, 80078, Italy

Location

Ospedale San Pietro Fatebenefratelli

Rome, 00189, Italy

Location

MeSH Terms

Conditions

Tachycardia; Ventricular Fibrillation; Ventricular Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Sample size is rather small and the power of the study is only 80%

Results Point of Contact

• Title: Anneleen Viville
• Organization: Boston Scientific

anneleen.viville@bsci.com

0032479983495

Study Officials

• Maria Grazia Bongiorni, MD

  University Hospital Pisa, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 17, 2013
• Study Start: December 16, 2013
• Primary Completion: November 2, 2015
• Study Completion: November 13, 2017
• Last Updated: April 30, 2019
• Results First Posted: November 20, 2017

Record last verified: 2019-04

Locations

IT (7); IL (3); DE (1)