ECG Belt vs. Echocardiographic Optimization of CRT

Not Applicable

Completed

• Conditions: Heart Failure, Systolic
• Interventions: Diagnostic Test: Optimization of CRT Device

• Registration Number: NCT03305692
• Lead Sponsor: Alan J. Bank, MD

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-10
• Study Start: 2017-10-31
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Echocardiography	Optimization of CRT Device	Use mitral inflow echocardiography to optimize CRT programming.
ECG Belt	Optimization of CRT Device	Use ECG Belt body surface mapping system to optimize CRT programming.

Primary Outcome Measures

Name	Time	Method
Echocardiographic assessment of LV function	6 months post optimization	Change in ejection fraction
Echocardiographic assessment of LV size	6 months post optimization	Change in left ventricular end-systolic volume

Trial Locations

Locations (1)

United Heart & Vascular Clinic; 🇺🇸 Saint Paul, Minnesota, United States