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Safety and Performance Study of the Reliance 4-Front Lead

NCT01772576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2017-07-02

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™ Active Fixation Defibrillation Leads.

Conditions

  • Tachycardia

Interventions

DEVICE

Reliance 4-Front lead implantation

The patients selected for participation should be from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.

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
2012-10-31
Primary Completion
2014-06-30
Completion
2016-08-31
FDA Device
Yes

Countries

  • Austria
  • China
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

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 NCT01772576 on ClinicalTrials.gov