Narrow QRS HF Patients Assessed by ECG Belt

NCT ID: NCT03367104

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-14

Study Completion Date

2021-08-17

Brief Summary

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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

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Conditions

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Heart Failure Cardiac Resynchronization Therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal healthy controls

ECG Belt

Intervention Type DEVICE

Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.

Heart failure patients

ECG Belt

Intervention Type DEVICE

Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.

Interventions

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ECG Belt

Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allina Health System

OTHER

Sponsor Role lead

Responsible Party

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Alan J. Bank, MD

Medical Director of Research - UHVC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Bank, MD

Role: PRINCIPAL_INVESTIGATOR

Allina Health System

Locations

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United Heart & Vascular Clinic

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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ERP 3771

Identifier Type: -

Identifier Source: org_study_id

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