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ECG Belt vs. Echocardiographic Optimization of CRT

NCT03305692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-09-27

No results posted yet for this study

Summary

Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.

Conditions

  • Heart Failure, Systolic

Interventions

DIAGNOSTIC_TEST

Optimization of CRT Device

Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Alan J. Bank, MD

    lead OTHER

Principal Investigators

  • Alan Bank, MD · United Heart & Vascular Clinic - Allina Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2021-08-17
Completion
2021-08-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305692 on ClinicalTrials.gov