ECG Belt vs. Echocardiographic Optimization of CRT

Alan J. Bank, MD

Status

Completed

Conditions

Heart Failure, Systolic

Treatments

Diagnostic Test: Optimization of CRT Device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03305692

ERP 3890

Details and patient eligibility

About

Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.

Full description

This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.

Enrollment

3 patients

Sex

All

Ages

18 to 110 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing and able to provide informed consent for participation in the study
Age ≥18 years
Received a first-time CRT device for standard clinical indication (can be upgraded from non-CRT pacemaker or defibrillator if ventricular pacing < 10%)
Adequate echocardiographic images for EF & LVESV determination

Exclusion criteria

Unhealed open wounds on the torso and/or a history of documented severe allergic reactions from ECG electrode gel
Enrollment in a concurrent study that could confound the results of this study
Pregnant or could become pregnant within the 6 month follow-up period
Non-ischemic cardiomyopathy, LBBB morphology, and QRSd > 150 ms
Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing < 90% over the 6 month follow-up period