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CompletedNCT00812201ELEVATEUpdated Jun 28, 2022

Evaluation of Left Ventricular AutoThreshold

An observational study in Heart Failure, sponsored by Boston Scientific Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by Boston Scientific Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart failure
  • auto threshold
  • pacing
  • CRT-P or CRT-D recipients, threshold measurements
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 80 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (actual)

Groups and cohorts

  • 1

    Device: No intervention is used. Collection of signals only.

Interventions

  • DeviceNo intervention is used. Collection of signals only.

    Device received per standard of care.

06

What researchers measure

Primary outcomes

  1. The objective of this study is to collect data to characterize the performance of the LVAT feature.

    Time frame: Implant

07

Study locations

2 sites
  • Virginia Commonwealth University Health System
    Richmond, Virginia 23298, United States
  • Monongalia General Hospital
    Morgantown, West Virginia 26505, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00812201
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Dec 22, 2008
Start date
Dec 2008
Primary completion
May 2009
Completion
Oct 2009
Last update
Jun 28, 2022

Study contacts

Kenneth L. Ellenbogen, M.D.
principal investigator · Virginia Commonwealth University Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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