ECG Belt for CRT Response

NCT03504020 | Completed Results DMC FDA Device

• 1 other identifier: ECG Belt for CRT Response
• Study Type: interventional
• Target: 498
• Locations: 7 countries
• Sites: 43

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ECG Belt

EXPERIMENTAL

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

Device: ECG Belt Research System

Control Arm

NO INTERVENTION

Standard CRT through 6 months follow-up.

Interventions

ECG Belt Research System DEVICE

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

ECG Belt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (43)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

Florida Hospital Cardiovascular Research Institute

Orlando, Florida, 32803-1248, United States

Location

BayCare Health System

Tampa, Florida, 33614-7101, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201-1718, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Heartland Cardiology

Wichita, Kansas, 67205-1138, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Advanced Cardiovascular Specialists

Shreveport, Louisiana, 71105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Lukes Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960-6136, United States

Location

Atrium Health's Carolina Medical Center

Charlotte, North Carolina, 28203-5867, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

North Carolina Heart and Vascular

Raleigh, North Carolina, 27607-7521, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Mount Carmel East

Columbus, Ohio, 43213, United States

Location

OhioHealth Research and Innovation Institute (OHRI)

Columbus, Ohio, 43214, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Lehigh Valley Hospital- Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213-2536, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0001, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660-7332, United States

Location

Vanderbilt University medical Center

Nashville, Tennessee, 37232-8802, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Texas Health Research & Education Institute

Fort Worth, Texas, 76104, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401-1473, United States

Location

Aurora St. Lukes

Milwaukee, Wisconsin, 53215, United States

Location

Onze-Lieve-Vrouwziekenhuis-campus aalst

Aalst, 9300, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Policlinico Sant' Orsola - Malpighi

Bologna, 40138, Italy

Location

Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca

Milan, 20149, Italy

Location

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, 6229 HX, Netherlands

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related 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.

  PMID: 32537740 RESULT

• 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.

  PMID: 36442824 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: CRM Clinical
• Organization: Medtronic CRM Clincial Research

medtroniccrmtrials@medtronic.com

800-328-2518

Study Officials

• ECG Belt for CRT Response Clinical Research Specialist

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: July 13, 2018
• Primary Completion: January 7, 2022
• Study Completion: April 20, 2022
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (34); CA (2); DK (1); IT (2); NL (1); CH (1); BE (2)