Heart Sounds Registry - Full Text View

Purpose

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.

Condition	Intervention
Heart Failure; With Decompensation	Device: Wearable Cardioverter Defibrillator (WCD)


Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration:	3 Months
Official Title:	Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:

Observe the changes in the heart sounds measurement [ Time Frame: 3 months ]
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.


Estimated Enrollment:	300
Actual Study Start Date:	June 5, 2017
Estimated Study Completion Date:	June 2019
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Intervention Details:

Observe and compare the heart sound measurements recorded by the WCD

Other Names:

LifeVest
WCD

Detailed Description:

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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03203629

Contacts


Contact: Mike A Osz, B.Sc.	412-968-3472	mosz@zoll.com

Locations


United States, South Carolina
McLeod Regional	Recruiting
Florence, South Carolina, United States, 29506

Sponsors and Collaborators

Zoll Medical Corporation

Investigators


Study Director:	Mike A Osz, B.Sc.	Zoll Medical Corporation

More Information


Responsible Party:	Zoll Medical Corporation
ClinicalTrials.gov Identifier:	NCT03203629 History of Changes
Other Study ID Numbers:	90D0164
Study First Received:	June 14, 2017
Last Updated:	June 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


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:		No
Pediatric Postmarket Surveillance of a Device Product:		No
Product Manufactured in and Exported from the U.S.:		Yes

Additional relevant MeSH terms:


Heart Failure Heart Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 21, 2017

Heart Sounds Registry (HEARIT-Reg)