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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
Sponsored by
Alan J. Bank, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
September 26, 2017
Last Updated
September 21, 2021
Sponsor
Alan J. Bank, MD
Collaborators
Medtronic
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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
No
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.
No
Data Monitoring Committee
No

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
No
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
No
IPD Sharing Plan Description
We do not plan to share IPD with other researchers.

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ECG Belt vs. Echocardiographic Optimization of CRT

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