ECG Belt vs. Echocardiographic Optimization of CRT

Launched by ALAN J. BANK, MD · Oct 6, 2017

Keywords

ClinConnect Summary

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 branc...

Gender

ALL

Eligibility criteria

• 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