Evaluation of Left Ventricular AutoThreshold (ELEVATE)

June 27, 2022 updated by: Boston Scientific Corporation
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Health System
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Monongalia General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Device: No intervention is used. Collection of signals only.
Device received per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The objective of this study is to collect data to characterize the performance of the LVAT feature.
Time Frame: Implant
Implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Kenneth L. Ellenbogen, M.D., Virginia Commonwealth University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRRT081908H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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