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ECG Belt vs. Echocardiographic Optimization of CRT

Primary Purpose

Heart Failure, Systolic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Optimization of CRT Device

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring cardiac resynchronization therapy, pacing, echocardiography, optimization, heart failure

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

United Heart & Vascular Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ECG Belt

Echocardiography

Arm Description

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

Use mitral inflow echocardiography to optimize CRT programming.

Outcomes

Primary Outcome Measures

Echocardiographic assessment of LV function

Change in ejection fraction

Echocardiographic assessment of LV size

Change in left ventricular end-systolic volume

Secondary Outcome Measures

Full Information

NCT ID

NCT03305692

First Posted

September 26, 2017

Last Updated

September 21, 2021

Sponsor

Alan J. Bank, MD

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT03305692

Brief Title

ECG Belt vs. Echocardiographic Optimization of CRT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

October 31, 2017 (Actual)

Primary Completion Date

August 17, 2021 (Actual)

Study Completion Date

August 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alan J. Bank, MD

Collaborators

Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Systolic

Keywords

cardiac resynchronization therapy, pacing, echocardiography, optimization, heart failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1 randomization

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ECG Belt

Arm Type

Experimental

Arm Description

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

Arm Title

Echocardiography

Arm Type

Experimental

Arm Description

Use mitral inflow echocardiography to optimize CRT programming.

Intervention Type

Diagnostic Test

Intervention Name(s)

Optimization of CRT Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Echocardiographic assessment of LV function

Description

Change in ejection fraction

Time Frame

6 months post optimization

Title

Echocardiographic assessment of LV size

Description

Change in left ventricular end-systolic volume

Time Frame

6 months post optimization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

110 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Bank, MD

Organizational Affiliation

United Heart & Vascular Clinic - Allina Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

United Heart & Vascular Clinic

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan to share IPD with other researchers.

Learn more about this trial

ECG Belt vs. Echocardiographic Optimization of CRT

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