ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0 (ELEVATE 3)

December 4, 2012 updated by: Boston Scientific Corporation

Evaluation of Left Ventricular Autothreshold

This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.

Study Type

Observational

Enrollment (Actual)

50

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
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center
    • Pennsylvania
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • Virginia
      • Richmond, Virginia, United States, 23298-0053
        • Virginia Commonwealth University Health System
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Wheaton Franciscan Health Care

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

The study population will be a sample of patients with COGNIS CRT-D devices.

Description

Inclusion Criteria:

  • Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
  • Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead
  • Patients who have an active LV bipolar or unipolar lead
  • Patients who have an active RV defibrillation lead
  • Patients who are willing and capable of participating in all testing associated with this Clinical Investigation

Exclusion Criteria:

  • Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
  • Patients who are pacemaker-dependent as defined as VVI 40 without intrinsic atrial or ventricular activity
  • Patients who will not tolerate a pacing pause of up to 6 seconds
  • Patients with a pre-existing unipolar pacemaker
  • Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
  • Patients enrolled in any concurrent study, without Boston Scientific CRM written approval
  • Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.

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
Pulse Width
One group reflecting two different pulse widths.
Device: Cardiac pacing
Cadiac pacing via a pulse generator and implaned intracardiac leads.
Other Names:
  • COGNIS PG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.
Time Frame: Minimum of 24 hrs post CRT-D implant.
The primary objective of this study is to collect real-time signals during LV pacing and voltage step-down from patients with implanted COGNIS devices.
Minimum of 24 hrs post CRT-D 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, MD, 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

March 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEVATE 3.0

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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