Heart Sounds Registry

Heart Failure; With Decompensation Clinical Trial

— HEARIT-Reg  

Official title:

Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203629
• Other study ID #: 90D0164
• Status: Completed
• Start date: June 5, 2017
• Est. completion date: March 16, 2021

Study information

• Verified date: April 2021
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: March 16, 2021
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

Device:
• Wearable Cardioverter Defibrillator (WCD)
Observe and compare the heart sound measurements recorded by the WCD

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Germany	Charité Berlin Benjamin Franklin	Berlin
Germany	Herzzentrum Dresden	Dresden
Germany	Uni Erlangen	Erlangen
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus	Hamburg
Germany	Asklepios St. Georg Hamburg	Hamburg
Germany	Sana Klinikum Hof,	Hof
Germany	Krankenhaus und MVZ Maria-Hilf Stadtlohn GmbH	Stadtlohn
Germany	University of Würzburg, Medizinische Klinik und Poliklinik I	Würzburg
Poland	American Heart of Poland S.A.	Chrzanów
Poland	Wissmed Gdanskie Centrum	Gdansk
Poland	Klinika Elektrokardiologii Uniwersytetu Medycznego w Lodzi	Lodz
Poland	EMED Centrum Uslug Medycznych	Rzeszow
Poland	Spzoz Msw	Rzeszow
Poland	Wojewodzki Szpital Zespolony	Torun
United States	MD First Research	Anderson	South Carolina
United States	JFK Medical Center	Atlantis	Florida
United States	Cardiovascular Institute of Michigan	Clinton Township	Michigan
United States	McLeod Regional	Florence	South Carolina
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	FRANCISCAN HEALTH Indianapolis	Indianapolis	Indiana
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Virtua The Cardiology Group	Moorestown	New Jersey
United States	West Virginia University Research	Morgantown	West Virginia
United States	MD Strategies Research Center	National City	California
United States	Chippenham Medical Center	Richmond	Virginia
United States	Michigan CardioVascular Institute	Saginaw	Michigan
United States	Northside Hospital / Heart Institute	Saint Petersburg	Florida
United States	Saratoga Clinical Research	Saratoga Springs	New York
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Virtua The Cardiology Group	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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