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NCT03367104 Clinical Trial

Narrow QRS HF Patients Assessed by ECG Belt

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03367104
Other study ID # ERP 3771
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 14, 2017
Est. completion date August 17, 2021

Study information
Verified date September 2021
Source Allina Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 17, 2021
Est. primary completion date August 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• ECG Belt
Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.

Locations
Country Name City State
United States United Heart & Vascular Clinic Saint Paul Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Electrical dyssynchrony quantification Collect ECG data with ECG Belt through acute study completion (~60 minutes)
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