Evaluation of Left Ventricular Autothreshold, Phase Two

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Left Ventricular Autothreshold, Phase Two

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT-D


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Two experimental and/or intervention groups under 1 arm. | Device: CRT-D<br>* Cardiac pacing via a pulse generator and implanted intracardiac leads<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing | 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 | At least 24 hours post CRT-D implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, auto threshold, pacing, CRT-D recipients, Left Ventricular (LV) evoked response signals