Evaluation of Left Ventricular AutoThreshold (ELEVATE)

Boston Scientific

Status: Completed

Conditions: Heart Failure

Treatments: Device: No intervention is used. Collection of signals only.

Study type: Observational

Funder types: Industry

Identifiers

NCT00812201

CRRT081908H

Details and patient eligibility

About

This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

Full description

ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
• Patients who are willing and capable of participating in all testing associated with this study
• Patients who are 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

• Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, 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 (unless the Investigator intends to replace them with permitted leads)
• Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
• Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
• Patients with a prosthetic mechanical tricuspid heart valve
• Women who are pregnant

Trial design

80 participants in 1 patient group

1

Treatment:

Device: No intervention is used. Collection of signals only.