ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01539629

Run by

Boston Scientific Corporation

People needed

50

Starts

2012-03-01

Expected to finish

2012-11-01

Last updated by the study team

2012-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Genesis Medical Center — Davenport, Iowa, United States
• Cardiology Consultants of Philadelphia — Yardley, Pennsylvania, United States
• Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Wheaton Franciscan Health Care — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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