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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01242722
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : October 3, 2012
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Failure Device: CRT-D

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
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Left Ventricular Autothreshold, Phase Two
Study Start Date : November 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Two experimental and/or intervention groups under 1 arm.
Device: CRT-D
Cardiac pacing via a pulse generator and implanted intracardiac leads

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01242722

United States, Ohio
Regional Cardiovascular Medical Center
Stuebenville, Ohio, United States, 43952
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Kenneth L Ellenbogen, M.D. Virginia Commonwealth University Health System

Responsible Party: Boston Scientific Corporation Identifier: NCT01242722     History of Changes
Other Study ID Numbers: ELEVATE 2.0
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by Boston Scientific Corporation:
Heart failure
auto threshold
CRT-D recipients
Left Ventricular (LV) evoked response signals

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases