Clinical trial NCT02699944: Optimization of CRT Using an ECG Vest
Official title: Optimization of Cardiac Resynchronization Therapy Using an ECG Vest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Allina Health System
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-03-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change in left ventricular end-systolic volume
timeFrame: 6 months after optimization
Secondary outcomes:
measure: Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures
timeFrame: 6 months after optimization
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: United Heart & Vascular Clinic
state: Minnesota
Study officials:
affiliation: Medical Director of Research
name: Alan J Bank, MD
role: PRINCIPAL_INVESTIGATOR
References: