ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0

Completed

• Conditions: Heart Failure
• Interventions: Device: Cardiac pacing

• Registration Number: NCT01539629
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Study Start: 2012-03
• Primary Completion: 2012-06
• Status Verified: 2012-10
• Study Completion: 2012-11
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulse Width	Cardiac pacing	One group reflecting two different pulse widths.

Primary Outcome Measures

Name	Time	Method
Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.	Minimum of 24 hrs post CRT-D implant.	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.

Trial Locations

Locations (4)

Genesis Medical Center; 🇺🇸 Davenport, Iowa, United States

Wheaton Franciscan Health Care; 🇺🇸 Wauwatosa, Wisconsin, United States

Cardiology Consultants of Philadelphia; 🇺🇸 Yardley, Pennsylvania, United States

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