Skip to main content
OpenTrials
Completed

NCT Number: NCT01539629

ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Genesis Medical Center, Davenport, Iowa, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac pacing

Device

Cadiac pacing via a pulse generator and implaned intracardiac leads.

Other names: COGNIS PG.

Primary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Evaluation of Left Ventricular Autothreshold

Acronym: ELEVATE 3

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2012
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.