This study is in progress, not accepting new patients

Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

a study on Heart Failure

Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Lead survivability will be summarized.

Official Title

Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Details

The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

Keywords

Heart Failure

Eligibility

Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive an Attain Ability Model 4396 LV lead
  • Patient within 30 day post implant enrollment window

Exclusion Criteria

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Locations

  • University of California San Francisco UCSF Medical Center
    San Francisco California 94143 United States
  • Cardiovascular Consultants Medical Group
    Van Nuys California 91405 United States
  • Redding Heart Care
    Redding California 96001 United States
  • COR Healthcare
    Torrance California 90503 United States
  • HealthCare Partners CCNV
    Henderson Nevada 89052 United States
  • Eisenhower Desert Cardiology Center
    Rancho Mirage California 92270 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic
ID
NCT01361685
Study Type
Observational
Last Updated
November 29, 2017