Clinical trial NCT03504020: ECG Belt for CRT Response
Official title: ECG Belt for CRT Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.
timeFrame: baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Health Shands Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cardiovascular Research Institute
state: Florida
city: Tampa
country: United States
facility: BayCare Health System
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Wichita
country: United States
facility: Heartland Cardiology
state: Kansas
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Shreveport
country: United States
facility: Advanced Cardiovascular Specialists
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Saint Lukes Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Atrium Health's Carolina Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute (OHRI)
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital- Cedar Crest
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Research & Education Institute
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Milwaukee
country: United States
facility: Aurora St. Lukes
state: Wisconsin
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis-campus aalst
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Kobenhavn
country: Denmark
facility: Rigshospitalet
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola - Malpighi
city: Milano
country: Italy
facility: Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum (MUMC)
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Medtronic
name: ECG Belt for CRT Response Clinical Research Specialist
role: STUDY_CHAIR
References:
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.
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.