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Completed

NCT Number: NCT03367104

Narrow QRS HF Patients Assessed by ECG Belt

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.

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Key information

Conditions

Heart Failure Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECG Belt

Device

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

Primary outcomes

  1. Electrical dyssynchrony quantification

    Time frame: through acute study completion (~60 minutes)

    Collect ECG data with ECG Belt

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Official study title

Electrical Dyssynchrony in Narrow QRS Heart Failure Patients as Assessed by the ECG Belt

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2017
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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