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Attain Performa(TM) Quadripolar Lead Study

NCT01751022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1202

Last updated 2016-12-05

Study results available
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Summary

The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.

Conditions

Interventions

DEVICE

Device: Attain Performa Pacing Lead (along with a standard CRT-D system)

Implant and follow-up of study lead, separate analysis for each lead model

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Norway
  • Romania
  • Saudi Arabia
  • Serbia
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT01751022 on ClinicalTrials.gov