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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01539629
First received: February 22, 2012
Last updated: December 4, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure
 Device: Cardiac pacing

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

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 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pulse Width
One group reflecting two different pulse widths.
 Device: Cardiac pacing
Cadiac pacing via a pulse generator and implaned intracardiac leads.
Other Name: COGNIS PG.

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.

  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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539629

Locations
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
United States, Pennsylvania
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States, 19067
United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298-0053
United States, Wisconsin
Wheaton Franciscan Health Care
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Kenneth L Ellenbogen, MD Virginia Commonwealth University Health System
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01539629     History of Changes
Other Study ID Numbers: ELEVATE 3.0
Study First Received: February 22, 2012
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Heart failure
Autothreshold
Pacing
CRT-D recipients
Left Ventricular evoked response signals

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013