Narrow QRS HF Patients Assessed by ECG Belt

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: Heart Failure; Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: ECG Belt

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

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	Collect ECG data with ECG Belt	through acute study completion (~60 minutes)

Collaborators and Investigators

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

Study record dates

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: Heart Diseases; Cardiovascular Diseases; Heart Failure
• 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