Narrow QRS HF Patients Assessed by ECG Belt

Completed

• Conditions: Cardiac Resynchronization Therapy; Heart Failure
• Interventions: Device: ECG Belt

• Registration Number: NCT03367104
• Lead Sponsor: Allina Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-08
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal healthy controls	ECG Belt	-
Heart failure patients	ECG Belt	-

Primary Outcome Measures

Name	Time	Method
Electrical dyssynchrony quantification	through acute study completion (~60 minutes)	Collect ECG data with ECG Belt

Trial Locations

Locations (1)

United Heart & Vascular Clinic; 🇺🇸 Saint Paul, Minnesota, United States