Clinical trial NCT03203629: Heart Sounds Registry
Official title: Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure; With Decompensation
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2017-06-29
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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: 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 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.

Primary outcomes:
measure: Observe the changes in the heart sounds measurement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: MD Strategies Research Center
state: California
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital / Heart Institute
state: Florida
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: FRANCISCAN HEALTH Indianapolis
state: Indiana
city: Clinton Township
country: United States
facility: Cardiovascular Institute of Michigan
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Saginaw
country: United States
facility: Michigan CardioVascular Institute
state: Michigan
city: Moorestown
country: United States
facility: Virtua The Cardiology Group
state: New Jersey
city: Voorhees
country: United States
facility: Virtua The Cardiology Group
state: New Jersey
city: Saratoga Springs
country: United States
facility: Saratoga Clinical Research
state: New York
city: Anderson
country: United States
facility: MD First Research
state: South Carolina
city: Florence
country: United States
facility: McLeod Regional
state: South Carolina
city: Richmond
country: United States
facility: Chippenham Medical Center
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Research
state: West Virginia
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Berlin
country: Germany
facility: Charité Berlin Benjamin Franklin
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Erlangen
country: Germany
facility: Uni Erlangen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus
city: Hamburg
country: Germany
facility: Asklepios St. Georg Hamburg
city: Hof
country: Germany
facility: Sana Klinikum Hof,
city: Stadtlohn
country: Germany
facility: Krankenhaus und MVZ Maria-Hilf Stadtlohn GmbH
city: Würzburg
country: Germany
facility: University of Würzburg, Medizinische Klinik und Poliklinik I
city: Chrzanów
country: Poland
facility: American Heart of Poland S.A.
city: Gdansk
country: Poland
facility: Wissmed Gdanskie Centrum
city: Lodz
country: Poland
facility: Klinika Elektrokardiologii Uniwersytetu Medycznego w Lodzi
city: Rzeszow
country: Poland
facility: Spzoz Msw
city: Rzeszow
country: Poland
facility: EMED Centrum Uslug Medycznych
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony
Study officials:
affiliation: Zoll Medical Corporation
name: Steven J. Szymkiewicz, MD
role: STUDY_DIRECTOR
References: