Evaluation of Left Ventricular Autothreshold, Phase Two

Completed

• Conditions: Heart Failure
• Interventions: Device: CRT-D

• Registration Number: NCT01242722
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.

Detailed Description

ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-02
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead
• Patients who have an active LV bipolar lead
• Patients who have an active right ventricular (RV) defibrillation lead
• Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
• Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law

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
• Patients who will not tolerate a pacing pause of up to 6 seconds
• Patients who have a unipolar LV pace/sense lead, 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
• Patients with a pre-existing unipolar pacemaker
• Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
• Patients enrolled in any concurrent study, without Boston Scientific written approval
• Women who are pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	CRT-D	Two experimental and/or intervention groups under 1 arm.

Primary Outcome Measures

Name	Time	Method
Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing	At least 24 hours post CRT-D implant	The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device

Trial Locations

Locations (1)

Regional Cardiovascular Medical Center; 🇺🇸 Stuebenville, Ohio, United States