Evaluation of Left Ventricular Autothreshold, Phase Two (ELEVATE 2)

October 2, 2012 updated by: Boston Scientific Corporation
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.

Study Type

Observational

Enrollment (Actual)

100

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
    • Ohio
      • Stuebenville, Ohio, United States, 43952
        • Regional Cardiovascular Medical Center

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 and bipolar LV leads.

Description

Inclusion Criteria:

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

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
  • Patients who will not tolerate a pacing pause of up to 6 seconds
  • Patients who have a unipolar LV pace/sense lead, 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
  • Patients with a pre-existing unipolar pacemaker
  • Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
  • Patients enrolled in any concurrent study, without Boston Scientific written approval
  • 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
Two experimental and/or intervention groups under 1 arm.
Device: CRT-D
Cardiac pacing via a pulse generator and implanted intracardiac leads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing
Time Frame: At least 24 hours post CRT-D implant
The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device
At least 24 hours 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, 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

November 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (ESTIMATE)

November 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEVATE 2.0

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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