Vanderbilt Clinical Trials

ECG Belt for CRT Response

Purpose

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.

Condition

Heart Failure

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts 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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ECG Belt	The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.	Device: ECG Belt Research System The ECG Belt Research System is used to identify the best vector and programming parameters.
No Intervention Control Arm	Standard CRT through 6 months follow-up.

More Details

Status: Completed
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.