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Narrow QRS HF Patients Assessed by ECG Belt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03367104
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Alan J. Bank, MD, 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.

Condition or disease Intervention/treatment
Heart Failure Cardiac Resynchronization Therapy Device: ECG Belt

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Study Type : Observational
Estimated Enrollment : 63 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 : November 14, 2017
Estimated Primary Completion Date : December 14, 2020
Estimated Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort 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.




Primary Outcome Measures :
  1. Electrical dyssynchrony quantification [ Time Frame: through acute study completion (~60 minutes) ]
    Collect ECG data with ECG Belt



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects and those with heart failure (reduced ejection fraction) with QRS duration ≤ 130 ms.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367104


Contacts
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Contact: Chris Brown 651-241-2806 Christopher.Brown2@allina.com

Locations
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United States, Minnesota
United Heart & Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Ryan Gage, MS    651-241-2810    Ryan.Gage@allina.com   
Principal Investigator: Alan Bank, MD         
Sponsors and Collaborators
Allina Health System
Investigators
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Principal Investigator: Alan Bank, MD Allina Health System
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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: December 8, 2017    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases