Heart Failure; With DecompensationHEARIT-RegNCT03203629
Heart Sounds Registry
An observational study of Heart Failure; With Decompensation, run by Zoll Medical Corporation at 33 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure; With Decompensation
- What is being tested?
- Wearable Cardioverter Defibrillator (WCD)
- Type of treatment
- Medical device
- How many people
- 705 participants
- Where
- 33 sitesin 4 countries
- Study dates
- 5 Jun 2017to 16 Mar 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
United States17 sites
MD First Research
Anderson, South Carolina, 29625
JFK Medical Center
Atlantis, Florida, 33462
Cardiovascular Institute of Michigan
Clinton Township, Michigan, 48038
McLeod Regional
Florence, South Carolina, 29506
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
FRANCISCAN HEALTH Indianapolis
Indianapolis, Indiana, 46237
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Virtua The Cardiology Group
Moorestown, New Jersey, 08057
West Virginia University Research
Morgantown, West Virginia, 26506
MD Strategies Research Center
National City, California, 91950
Chippenham Medical Center
Richmond, Virginia, 23225
Michigan CardioVascular Institute
Saginaw, Michigan, 48601
Saratoga Clinical Research
Saratoga Springs, New York, 12866
Northside Hospital / Heart Institute
St. Petersburg, Florida, 33709
Carle Foundation Hospital
Urbana, Illinois, 61801
Virtua The Cardiology Group
Voorhees Township, New Jersey, 08043
Germany9 sites
Charité Berlin Benjamin Franklin
Berlin
Herzzentrum Dresden
Dresden
Uni Erlangen
Erlangen, 91054
Universitätsklinikum Frankfurt
Frankfurt
Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus
Hamburg
Asklepios St. Georg Hamburg
Hamburg
Sana Klinikum Hof,
Hof
Krankenhaus und MVZ Maria-Hilf Stadtlohn GmbH
Stadtlohn
University of Würzburg, Medizinische Klinik und Poliklinik I
Würzburg
Poland6 sites
American Heart of Poland S.A.
Chrzanów, 32-500
Wissmed Gdanskie Centrum
Gdansk, 80-175
Klinika Elektrokardiologii Uniwersytetu Medycznego w Lodzi
Lodz, 92-213
Spzoz Msw
Rzeszów, 35-111
EMED Centrum Uslug Medycznych
Rzeszów, 35-205
Wojewodzki Szpital Zespolony
Torun, 87-100
About this study
Official title: Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol
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.
Read the 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.
- Conditions
- Heart Failure; With Decompensation
- Being tested
- Wearable Cardioverter Defibrillator (WCD)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Cardioverter Defibrillator (WCD)Device
Also called LifeVest, WCD
Observe and compare the heart sound measurements recorded by the WCD
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start5 Jun 2017
- Primary completion30 Jan 2020
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 705 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven J. Szymkiewicz, MD, Study director, Zoll Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203629
- Sponsor's protocol ID
- 90D0164
- Acronym
- HEARIT-Reg
- Status last verified
- Apr 2021
- First submitted
- 14 Jun 2017
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol
- ClinicalTrials.gov ID
- NCT03203629
- Acronym / sponsor ID
- HEARIT-Reg / 90D0164
- Conditions
- Heart Failure; With Decompensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Cardioverter Defibrillator (WCD)Also: LifeVest, WCDObserve and compare the heart sound measurements recorded by the WCD | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J. Szymkiewicz, MD study director
Zoll Medical Corporation
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure; With Decompensation, run by Zoll Medical Corporation at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Poland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe the changes in the heart sounds measurement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.