A Study to Evaluate an ECG Belt for CRT Response

Overview

About this study

The purpose of this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age 18 years or older.
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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Abhishek Deshmukh, M.B.B.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Abhishek Deshmukh, M.B.B.S.

Closed for enrollment

More information

Publications

Publications are currently not available

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