ECG Belt vs. Echocardiographic Optimization of CRT

September 21, 2021 updated by: Alan J. Bank, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • United Heart & Vascular Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic assessment of LV function
Time Frame: 6 months post optimization
Change in ejection fraction
6 months post optimization
Echocardiographic assessment of LV size
Time Frame: 6 months post optimization
Change in left ventricular end-systolic volume
6 months post optimization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alan J. Bank, MD

Collaborators

Medtronic

Investigators

  • Principal Investigator: Alan Bank, MD, United Heart & Vascular Clinic - Allina Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 31, 2017

Primary Completion (ACTUAL)

August 17, 2021

Study Completion (ACTUAL)

August 17, 2021

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (ACTUAL)

October 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERP 3890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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