Skip to main content
OpenTrials
Completed

NCT Number: NCT00812201

Evaluation of Left Ventricular AutoThreshold

This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University Health System, Richmond, Virginia, United States

Loading trial locations.

About this study

ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
  • Patients who are willing and capable of participating in all testing associated with this study
  • Patients who are 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

  • Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
  • Patients with pre-existing leads other than those specified in this investigational plan (unless the Investigator intends to replace them with permitted leads)
  • Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
  • Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
  • Patients with a prosthetic mechanical tricuspid heart valve
  • Women who are pregnant

Treatment and study plan

No intervention is used. Collection of signals only.

Device

Device received per standard of care.

Primary outcomes

  1. The objective of this study is to collect data to characterize the performance of the LVAT feature.

    Time frame: Implant

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: ELEVATE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.