Optimization of CRT Using an ECG Vest
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/29/2018 |
Start Date: | November 2015 |
End Date: | November 2019 |
Optimization of Cardiac Resynchronization Therapy Using an ECG Vest
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.
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.
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.
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.
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
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