Evaluation of Left Ventricular AutoThreshold (ELEVATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00812201
First received: December 18, 2008
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

This study will collect data on a new feature for future heart failure devices via an external non-implantable system.


Condition Intervention
Heart Failure
Device: No intervention is used. Collection of signals only.

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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • The objective of this study is to collect data to characterize the performance of the LVAT feature. [ Time Frame: Implant ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Device: No intervention is used. Collection of signals only.
Device received per standard of care.

Detailed Description:

ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold 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

Primary care clinic

Criteria

Inclusion Criteria:

  • Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
  • Patients who are willing and capable of participating in all testing associated with this study
  • Patients who are 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

  • Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, 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 (unless the Investigator intends to replace them with permitted leads)
  • Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
  • Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
  • Patients with a prosthetic mechanical tricuspid heart valve
  • Women who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812201

Locations
United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
United States, West Virginia
Monongalia General Hospital
Morgantown, West Virginia, United States, 26505
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: NCT00812201     History of Changes
Other Study ID Numbers: CRRT081908H
Study First Received: December 18, 2008
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-P or CRT-D recipients, threshold measurements

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014