ECG Belt for CRT Response

July 7, 2022 updated by: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.

Study Type

Interventional

Enrollment (Actual)

498

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

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
    • Quebec
      • Montréal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant' Orsola - Malpighi
      • Milano, Italy, 20149
        • Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum (MUMC)
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Health Shands Hospital
      • Orlando, Florida, United States, 32803-1248
        • Florida Hospital Cardiovascular Research Institute
      • Tampa, Florida, United States, 33614-7101
        • BayCare Health System
    • Illinois
      • Evanston, Illinois, United States, 60201-1718
        • NorthShore University Health System
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Wichita, Kansas, United States, 67205-1138
        • Heartland Cardiology
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
      • Shreveport, Louisiana, United States, 71105
        • Advanced Cardiovascular Specialists
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Lukes Hospital of Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Heart
    • New Jersey
      • Morristown, New Jersey, United States, 07960-6136
        • Morristown Memorial Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203-5867
        • Atrium Health's Carolina Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27607-7521
        • North Carolina Heart and Vascular
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research and Innovation Institute (OHRI)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital- Cedar Crest
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2536
        • University of Pittsburgh Medical Center UPMC Presbyterian
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0001
        • Medical University of South Carolina
    • Tennessee
      • Kingsport, Tennessee, United States, 37660-7332
        • Wellmont CVA Heart Institute
      • Nashville, Tennessee, United States, 37232-8802
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Fort Worth, Texas, United States, 76104
        • Texas Health Research & Education Institute
    • Vermont
      • Burlington, Vermont, United States, 05401-1473
        • The University of Vermont Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Lukes

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
  • Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB
  • LVEDD ≥ 55 mm, as determined by site

Exclusion Criteria:

  • Permanent/persistent AF or presenting with AF
  • Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator
  • Currently implanted with IPG or ICD with > 10% RV pacing
  • Permanent complete AV block
  • Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
  • Less than 1 year life expectancy
  • Vulnerable adults
  • Younger than 18 years of age

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECG Belt
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
Device: ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.
No Intervention: Control Arm
Standard CRT through 6 months follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in left ventricular end systolic volume (LVESV) from baseline to 6 months post-implant.
Time Frame: baseline to 6 months
baseline to 6 months

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: ECG Belt for CRT Response Clinical Research Specialist, Medtronic

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)

July 13, 2018

Primary Completion (Actual)

January 7, 2022

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECG Belt for CRT Response

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.

Yes

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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