Narrow QRS HF Patients Assessed by ECG Belt | NCT03367104

Studies
Narrow QRS HF Patients Assessed by ECG Belt

NCT03367104

Sponsor

Allina Health System

Status

Completed

Last Update Posted

Sep 23, 2021Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Heart Failure
Cardiac Resynchronization Therapy

Interventions

ECG Belt

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 14, 2017Actual

Primary Completion Date

Aug 17, 2021Actual

Completion Date

Aug 17, 2021Actual

First Submitted Date

Dec 4, 2017

First Submission Date that Met QC Criteria

Dec 7, 2017

First Posted Date

Dec 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2021

Last Update Posted Date

Sep 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal healthy controls			Device: ECG Belt
Heart failure patients			Device: ECG Belt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECG Belt	Device	Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.	Heart failure patients Normal healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electrical dyssynchrony quantification	Collect ECG data with ECG Belt	through acute study completion (~60 minutes)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Bank, MD	Allina Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
United Heart & Vascular Clinic		Saint Paul	Minnesota	55102	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided