Evaluation of Left Ventricular Autothreshold, Phase Two (ELEVATE 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01242722
First received: November 12, 2010
Last updated: October 2, 2012
Last verified: October 2012

November 12, 2010
October 2, 2012
November 2010
March 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01242722 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Evaluation of Left Ventricular Autothreshold, Phase Two
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population will be a sample of patients with COGNIS CRT-D devices and bipolar LV leads.

Heart Failure
Device: CRT-D
Cardiac pacing via a pulse generator and implanted intracardiac leads
1
Two experimental and/or intervention groups under 1 arm.
Intervention: Device: CRT-D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01242722
ELEVATE 2.0
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Kenneth L Ellenbogen, M.D. Virginia Commonwealth University Health System
Boston Scientific Corporation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP