Heart Failure Clinical Trial
Heart Sounds Registry
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.
Full 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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 24 Locations for this study
National City California, 91950, United States
Atlantis Florida, 33462, United States
Fort Lauderdale Florida, 33308, United States
Saint Petersburg Florida, 33709, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46237, United States
Clinton Township Michigan, 48038, United States
Grand Blanc Michigan, 48439, United States
Lansing Michigan, 48912, United States
Saginaw Michigan, 48601, United States
Moorestown New Jersey, 08057, United States
Voorhees New Jersey, 08043, United States
Saratoga Springs New York, 12866, United States
Anderson South Carolina, 29625, United States
Florence South Carolina, 29506, United States
Richmond Virginia, 23225, United States
Morgantown West Virginia, 26506, United States
Graz , , Austria
Berlin , , Germany
Dresden , , Germany
Erlangen , 91054, Germany
Frankfurt , , Germany
Hamburg , , Germany
Hamburg , , Germany
Hof , , Germany
Stadtlohn , , Germany
Würzburg , , Germany
Chrzanów , 32-50, Poland
Gdansk , 80-17, Poland
Lodz , 92-21, Poland
Rzeszow , 35-11, Poland
Rzeszow , 35-20, Poland
Torun , 87-10, Poland
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.