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ECG Belt for CRT Response | Clinical Trials | Clareo Health

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COMPLETEDNANCT03504020

ECG Belt for CRT Response

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) remodel...

Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure•34 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Medtronic Cardiac Rhythm and Heart Failure

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 3, 2023Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment498

Start dateJul 2018

Last updatedFeb 3, 2023

Condition

Locations shown

Hartford Hospital

Hartford, Connecticut

Yale School of Medicine

New Haven, Connecticut

MedStar Washington Hospital Center

Washington D.C., District of Columbia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2023Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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