Narrow QRS HF Patients Assessed by ECG Belt

• Sponsor: Allina Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT03367104
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Actual Duration (Months): 45.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Cardiac Resynchronization Therapy	Device: ECG Belt

Study Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Electrical Dyssynchrony in Narrow QRS Heart Failure Patients as Assessed by the ECG Belt
• Actual Study Start Date: Nov 14, 2017
• Actual Primary Completion Date: Aug 17, 2021
• Actual Study Completion Date: Aug 17, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Electrical dyssynchrony quantification [through acute study completion (~60 minutes)]

   Collect ECG data with ECG Belt

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Heart & Vascular Clinic	Saint Paul	Minnesota	United States	55102

Sponsors and Collaborators

• Allina Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alan J. Bank, MD, Medical Director of Research - UHVC, Allina Health System
• ClinicalTrials.gov Identifier: NCT03367104
• Other Study ID Numbers: ERP 3771
• First Posted: Dec 8, 2017
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Sep 23, 2021