ECG Belt for CRT Response

Medtronic logo

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

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.

Trial documents
2

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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