ECG Belt for CRT Response

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.

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