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

NCT01856491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2019-04-30

Study results available
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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

Interventions

DEVICE

RELIANCE 4-FRONT™ Passive Fixation lead implantation

Implantation of transvenous defibrillation lead with passive fixation mechanism.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Maria Grazia Bongiorni, MD · University Hospital Pisa, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2015-11-02
Completion
2017-11-13
FDA Device
Yes

Countries

  • Germany
  • Israel
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01856491 on ClinicalTrials.gov