Narrow QRS HF Patients Assessed by ECG Belt

September 21, 2021 updated by: Alan J. Bank, MD, Allina Health System

Electrical Dyssynchrony in Narrow QRS Heart Failure Patients as Assessed by the ECG Belt

The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and optimized using the ECG Belt.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • United Heart & Vascular Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects and those with heart failure (reduced ejection fraction) with QRS duration ≤ 130 ms.

Description

Inclusion Criteria:

  • Subject (or their legal guardian) must be willing to provide informed consent for their participation in the study
  • Subject ≥ 18 years old

Exclusion Criteria:

  • Subject has unhealed-open wounds on the torso and/or has a history of severe allergic reactions from ECG electrode gel
  • Subject is enrolled in a concurrent study that could confound the results of this study
  • Subject is pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal healthy controls
Device: ECG Belt
Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.
Heart failure patients
Device: ECG Belt
Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical dyssynchrony quantification
Time Frame: through acute study completion (~60 minutes)
Collect ECG data with ECG Belt
through acute study completion (~60 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allina Health System

Investigators

  • Principal Investigator: Alan Bank, MD, Allina Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

August 17, 2021

Study Completion (Actual)

August 17, 2021

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERP 3771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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