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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

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)