ECG Belt vs. Echocardiographic Optimization of CRT

Sponsor

Alan J. Bank, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03305692

Collaborator

Medtronic (Industry)

Enrollment

Location

Arms

45.5

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic	Diagnostic Test: Optimization of CRT Device	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomization1:1 randomization

Masking:

Single (Outcomes Assessor)

Masking Description:

Individual analyzing echocardiograms (primary outcome) will not know randomization of the subject.

Primary Purpose:

Treatment

Official Title:

Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization

Actual Study Start Date :

Oct 31, 2017

Actual Primary Completion Date :

Aug 17, 2021

Actual Study Completion Date :

Aug 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ECG Belt Use ECG Belt body surface mapping system to optimize CRT programming.	Diagnostic Test: Optimization of CRT Device Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.
Experimental: Echocardiography Use mitral inflow echocardiography to optimize CRT programming.	Diagnostic Test: Optimization of CRT Device Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.

Arm

Intervention/Treatment

Experimental: ECG Belt

Use ECG Belt body surface mapping system to optimize CRT programming.

Diagnostic Test: Optimization of CRT Device

Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.

Experimental: Echocardiography

Use mitral inflow echocardiography to optimize CRT programming.

Diagnostic Test: Optimization of CRT Device

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts 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