ECG Belt for CRT Response

Heart Failure Clinical Trial

Official title:

ECG Belt for CRT Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504020
• Other study ID #: ECG Belt for CRT Response
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: April 20, 2022

Study information

• Verified date: January 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: April 20, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis-campus aalst	Aalst
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Denmark	Rigshospitalet	Kobenhavn
Italy	Policlinico Sant' Orsola - Malpighi	Bologna
Italy	Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca	Milano
Netherlands	Maastricht Universitair Medisch Centrum (MUMC)	Maastricht
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United States	Lehigh Valley Hospital- Cedar Crest	Allentown	Pennsylvania
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	The University of Vermont Medical Center	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Atrium Health's Carolina Medical Center	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Mount Carmel East	Columbus	Ohio
United States	OhioHealth Research and Innovation Institute (OHRI)	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	NorthShore University Health System	Evanston	Illinois
United States	Texas Health Research & Education Institute	Fort Worth	Texas
United States	University of Florida Health Shands Hospital	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Saint Lukes Hospital of Kansas City	Kansas City	Missouri
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Bryan Heart	Lincoln	Nebraska
United States	Aurora St. Lukes	Milwaukee	Wisconsin
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Vanderbilt University medical Center	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Florida Hospital Cardiovascular Research Institute	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	North Carolina Heart and Vascular	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Advanced Cardiovascular Specialists	Shreveport	Louisiana
United States	BayCare Health System	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Heartland Cardiology	Wichita	Kansas
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Italy,  Netherlands,  Switzerland, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to 6 months