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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01242722
First received: November 12, 2010
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Heart Failure
 Device: CRT-D

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Left Ventricular Autothreshold, Phase Two

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 100
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Two experimental and/or intervention groups under 1 arm.
 Device: CRT-D
Cardiac pacing via a pulse generator and implanted intracardiac leads

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242722

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

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01242722     History of Changes
Other Study ID Numbers: ELEVATE 2.0
Study First Received: November 12, 2010
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013