Optimization of CRT Using an ECG Vest

Study Overview
=================
Brief Summary
-----------------
Despite advancements in implant technology and various techniques of optimization, there is still around 30% non-responder rate to cardiac resynchronization therapy (CRT). This study will assess the potential benefit of a body surface mapping technology to optimize CRT devices in the chronic sub-optimal responder setting.

Detailed Description
-----------------
Cardiac resynchronization therapy (CRT) is one of the most important advances in the treatment of patients with heart failure (HF). This therapy, also known as biventricular pacing, utilizes pacemaker leads to synchronize the contraction of the walls within the left ventricle (LV) and the contraction of the left and right ventricles. Many randomized trials have conclusively demonstrated that CRT improves symptoms, LV structure and function, hospitalization rates, and survival in appropriately selected HF patients. Nonetheless, approximately 30% of CRT patients will be non-responders because they will not demonstrate the expected clinical and/or echocardiographic improvement following therapy. A critical component of assessing CRT efficacy during the optimization clinic will be the use of a novel method of body surface electrocardiographic mapping under development by Medtronic, called the ECG Vest. In this proposal, we describe a research study to assess the potential benefit of using the ECG Vest as part of a CRT optimization strategy on clinical and echocardiographic outcomes (heart size and function) of patients receiving standard clinical care in the UHVC CRT Optimization Clinic.

Official Title
-----------------
Optimization of Cardiac Resynchronization Therapy Using an ECG Vest

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

Intervention / Treatment
-----------------
* Device: ECG Vest Optimization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (or their legal guardian) must be willing to provide Informed Consent and a data privacy (HIPPA) authorization Patient is or will be followed clinically in the UHVC CRT Optimization Clinic Patient has been implanted with a CRT device for at least 6 months Patient received an echocardiogram prior to CRT implant Patients must be ≥ 18 years of age Exclusion Criteria: Patient's EF is currently ≥ 50% Patients who are pregnant Patient has unhealed / open wounds on the torso and/or has a history of severe allergic reactions from ECG gel / electrode glue

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT sub-optimal responder<br>Subjects who have had CRT for at least 6 months and who have not responded as well as they could, in their cardiologists opinion. Subjects' ejection fraction are still <50% despite CRT. A ECG Vest Optimization protocol will be utilized as one aspect to determine the best CRT programming for each individual subject. | Device: ECG Vest Optimization<br>* As part of a standard and clinically indicated CRT optimization procedure utilize an ECG Vest as one modality for collecting information to determine best device programming.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular end-systolic volume |  | 6 months after optimization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures |  | 6 months after optimization |