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ECG Belt vs. Echocardiographic Optimization of CRT

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ClinicalTrials.gov Identifier: NCT03305692
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Alan J. Bank, MD, Allina Health System

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization
Masking: Single (Outcomes Assessor)
Masking Description: Individual analyzing echocardiograms (primary outcome) will not know randomization of the subjecdt.
Primary Purpose: Treatment
Official Title: Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. Echocardiographic assessment of LV function [ Time Frame: 6 months post optimization ]
    Change in ejection fraction

  2. Echocardiographic assessment of LV size [ Time Frame: 6 months post optimization ]
    Change in left ventricular end-systolic volume



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305692


Contacts
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Contact: Chris Brown 651-241-2806 Christopher.Brown2@allina.com

Locations
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United States, Minnesota
United Heart & Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Ryan M Gage, MS    651-241-2810    Ryan.Gage@allina.com   
Sponsors and Collaborators
Alan J. Bank, MD
Medtronic
Investigators
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Principal Investigator: Alan Bank, MD United Heart & Vascular Clinic - Allina Health System
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Responsible Party: Alan J. Bank, MD, Medical Director of Research - United Heart & Vascular Clinic, Allina Health System
ClinicalTrials.gov Identifier: NCT03305692    
Other Study ID Numbers: ERP 3890
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD with other researchers.

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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
Keywords provided by Alan J. Bank, MD, Allina Health System:
cardiac resynchronization therapy
pacing
echocardiography
optimization
heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases