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ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0 (ELEVATE 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01539629
First received: February 22, 2012
Last updated: December 4, 2012
Last verified: October 2012
History of Changes

February 22, 2012
December 4, 2012
March 2012
June 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01539629 on ClinicalTrials.gov Archive Site
Not Provided
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ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0
Evaluation of Left Ventricular Autothreshold

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.

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.
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.
Heart Failure
Device: Cardiac pacing
Cadiac pacing via a pulse generator and implaned intracardiac leads.
Other Name: COGNIS PG.
Pulse Width
One group reflecting two different pulse widths.
Intervention: Device: Cardiac pacing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01539629
ELEVATE 3.0
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Kenneth L Ellenbogen, MD 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