NCT03367104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

December 4, 2017

Last Update Submit

September 21, 2021

Conditions

Heart FailureCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

  • Electrical dyssynchrony quantification

    Collect ECG data with ECG Belt

    through acute study completion (~60 minutes)

Study Arms (2)

Normal healthy controls

Device: ECG Belt

Heart failure patients

Device: ECG Belt

Interventions

ECG BeltDEVICE

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

Heart failure patientsNormal healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects and those with heart failure (reduced ejection fraction) with QRS duration ≤ 130 ms.

You may qualify if:

  • Subject (or their legal guardian) must be willing to provide informed consent for their participation in the study
  • Subject ≥ 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alan Bank, MD

    Allina Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Research - UHVC

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 8, 2017

Study Start

November 14, 2017

Primary Completion

August 17, 2021

Study Completion

August 17, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)