Heart Failure
Conditions
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.
Interventions
DEVICEECG Vest Optimization
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.
Sponsors
Medtronic
Alan J. Bank, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in left ventricular end-systolic volume | 6 months after optimization |
Secondary
| Measure | Time frame |
|---|---|
| Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures | 6 months after optimization |
Countries
United States
Outcome results
None listed