Heart Sounds Registry | NCT03203629

Status Module

Record Verification Date

Apr 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

Jun 5, 2017Actual

Primary Completion Date

Jan 30, 2020Actual

Completion Date

Mar 16, 2021Actual

First Submitted Date

Jun 14, 2017

First Submission Date that Met QC Criteria

Jun 27, 2017

First Posted Date

Jun 29, 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

Apr 22, 2021

Last Update Posted Date

Apr 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.

Detailed Description

Participants will be adult (age ≥ 18 years) heart failure patients with an ejection fraction (EF) ≤ 35% and eligible to wear the WCD for at least 3 months.

An FDA-approved WCD will be prescribed for at least 3 months of use after hospital discharge.

This is a multi-center, prospective, observational study.

The study will enroll a total of 300 subjects, anticipating that at least 250 subjects will complete the study. A maximum of 50 sites will enroll patients into the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

705Actual

Name	Type	Description	Arm Group Labels	Other Names
Wearable Cardioverter Defibrillator (WCD)	Device	Observe and compare the heart sound measurements recorded by the WCD		LifeVest WCD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Observe the changes in the heart sounds measurement	Observe the changes in the heart sounds measurement (recorded by the WCD) with clinical evidence of heart failure decompensation during the three month WCD treatment period.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are prescribed the WCD ≤ 10 days post-discharge after hospitalization with Heart Failure (HF), with and ischemic or non-ischemic cardiomyopathy.
Patients who have an ejection fraction (EF) ≤ 35% at the time of WCD prescription.
Patients are anticipated to wear the WCD for at least 3 months.
The subject must be 18 years of age or older on the day of screening.

Exclusion Criteria:

Patients with pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device.
Patients waiting for heart transplant.
Patients with known evidence of atrial fibrillation on their most recent ECG recording.
Patients currently hospitalized for acute myocardial infarction.
Patients with a planned revascularization within 30 days of screening.
Patients who are self-reporting to be pregnant.
Patients participating in another clinical study.
Patients not expected to live longer than 1 year.
For patients in the United States, those who are unable or unwilling to provide written informed consent in English.
For patients in Europe, those who are unable or unwilling to provide written informed consent in their country specific language or English.

Accepts Healthy Volunteers

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

Participants will be adult (age ≥ 18 years) heart failure patients with an ejection fraction (EF) ≤ 35% and eligible to wear the WCD for at least 3 months.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Steven J. Szymkiewicz, MD	Zoll Medical Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
MD Strategies Research Center		National City	California	91950	United States
JFK Medical Center

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

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases