ECG Belt for CRT Response

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: ECG Belt Research System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03504020

ECG Belt for CRT Response

Details and patient eligibility

About

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.

Full 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.

Enrollment: 498 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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498 participants in 2 patient groups

ECG Belt

Experimental group

Description:

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

Treatment:

Device: ECG Belt Research System

Control Arm

No Intervention group

Description:

Standard CRT through 6 months follow-up.