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

Boston Scientific

Status: Completed

Conditions: Heart Failure

Treatments: Device: Cardiac pacing

Study type: Observational

Funder types: Industry

Identifiers

NCT01539629

ELEVATE 3.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Pulse Width

Description:

One group reflecting two different pulse widths.

Treatment:

Device: Cardiac pacing