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ECG Belt for CRT Response

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ECG Belt Research System
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hartford Hospital
  • Yale School of Medicine
  • MedStar Washington Hospital Center
  • University of Florida Health Shands Hospital
  • Florida Hospital Cardiovascular Research Institute
  • BayCare Health System
  • NorthShore University Health System
  • Iowa Heart Center
  • Heartland Cardiology
  • Cardiovascular Institute of the South
  • Advanced Cardiovascular Specialists
  • Mayo Clinic
  • Saint Lukes Hospital of Kansas City
  • Washington University School of Medicine
  • Bryan Heart
  • Morristown Memorial Hospital
  • Atrium Health's Carolina Medical Center
  • Duke University Medical Center
  • North Carolina Heart and Vascular
  • Cleveland Clinic
  • Mount Carmel East
  • OhioHealth Research and Innovation Institute (OHRI)
  • Oklahoma Heart Hospital
  • Lehigh Valley Hospital- Cedar Crest
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center UPMC Presbyterian
  • Geisinger Wyoming Valley Medical Center
  • Medical University of South Carolina
  • Wellmont CVA Heart Institute
  • Vanderbilt University medical Center
  • Texas Cardiac Arrhythmia Research Foundation
  • Texas Health Research & Education Institute
  • The University of Vermont Medical Center
  • Aurora St. Lukes
  • Onze-Lieve-Vrouwziekenhuis-campus aalst
  • Cliniques Universitaires Saint-Luc
  • University of Ottawa Heart Institute
  • Montreal Heart Institute
  • Rigshospitalet
  • Policlinico Sant' Orsola - Malpighi
  • Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
  • Maastricht Universitair Medisch Centrum (MUMC)
  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ECG Belt

Control Arm

Arm Description

The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.

Standard CRT through 6 months follow-up.

Outcomes

Primary Outcome Measures

Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.
Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.

Secondary Outcome Measures

Full Information

First Posted
April 12, 2018
Last Updated
January 31, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03504020
Brief Title
ECG Belt for CRT Response
Official Title
ECG Belt for CRT Response
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECG Belt
Arm Type
Experimental
Arm Description
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard CRT through 6 months follow-up.
Intervention Type
Device
Intervention Name(s)
ECG Belt Research System
Intervention Description
The ECG Belt Research System is used to identify the best vector and programming parameters.
Primary Outcome Measure Information:
Title
Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.
Description
Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.
Time Frame
baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ECG Belt for CRT Response Clinical Research Specialist
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Florida Hospital Cardiovascular Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1248
Country
United States
Facility Name
BayCare Health System
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1718
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Heartland Cardiology
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Advanced Cardiovascular Specialists
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Lukes Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6136
Country
United States
Facility Name
Atrium Health's Carolina Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203-5867
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
North Carolina Heart and Vascular
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-7521
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Mount Carmel East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
OhioHealth Research and Innovation Institute (OHRI)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Lehigh Valley Hospital- Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2536
Country
United States
Facility Name
Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0001
Country
United States
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660-7332
Country
United States
Facility Name
Vanderbilt University medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8802
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Health Research & Education Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1473
Country
United States
Facility Name
Aurora St. Lukes
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Onze-Lieve-Vrouwziekenhuis-campus aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Rigshospitalet
City
Kobenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Policlinico Sant' Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Maastricht Universitair Medisch Centrum (MUMC)
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32537740
Citation
Rickard J, Jackson K, Biffi M, Vernooy K, Bank A, Cerkvenik J, Ghosh S, Gold MR. The ECG Belt for CRT response trial: Design and clinical protocol. Pacing Clin Electrophysiol. 2020 Oct;43(10):1063-1071. doi: 10.1111/pace.13985. Epub 2020 Sep 1.
Results Reference
result
PubMed Identifier
36442824
Citation
Rickard J, Jackson K, Gold M, Biffi M, Ziacchi M, Silverstein J, Ramza B, Metzl M, Grubman E, Abben R, Varma N, Tabbal G, Jensen C, Wouters G, Ghosh S, Vernooy K; ECG Belt for CRT Response Study Group. Electrocardiogram Belt guidance for left ventricular lead placement and biventricular pacing optimization. Heart Rhythm. 2023 Apr;20(4):537-544. doi: 10.1016/j.hrthm.2022.11.015. Epub 2022 Nov 25.
Results Reference
result

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