Evaluation of Left Ventricular AutoThreshold

Completed

• Conditions: Heart Failure
• Interventions: Device: No intervention is used. Collection of signals only.

• Registration Number: NCT00812201
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2009-05
• Study Completion: 2009-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	No intervention is used. Collection of signals only.	-

Primary Outcome Measures

Name	Time	Method
The objective of this study is to collect data to characterize the performance of the LVAT feature.	Implant

Trial Locations

Locations (2)

Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States

Monongalia General Hospital; 🇺🇸 Morgantown, West Virginia, United States