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Completed

NCT Number: NCT01242722

Evaluation of Left Ventricular Autothreshold, Phase Two

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regional Cardiovascular Medical Center

Stuebenville, Ohio, 43952, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CRT-D

Device

Cardiac pacing via a pulse generator and implanted intracardiac leads

Primary outcomes

  1. 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

    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

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Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: ELEVATE 2

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 17, 2010
Registry last updated
Oct 3, 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.

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