Ischemic Heart FailureWEARIT-IIINCT02700880
LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry
An observational study of Ischemic Heart Failure, run by Zoll Medical Corporation at 1 site in United States.
Trial summary
The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Failure
- What is being tested?
- LifeVest
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Feb 2019
- How long will I take part?
- 12 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: In WEARIT-III, subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Cardioverter Defibrillator (WCD) and agree to enter the Registry after appropriate informed consent will be enrolled. It is anticipated that approximately 1000 patients with ischemic cardiomyopathy and heart failure (≥18 years of age) will be enrolled in 2 years. No individuals shall be excluded from participation in the Registry based on race, ethnicity or gender.
Who may be able to join
- Subjects of 18 years old or older;
- Subjects who are recently diagnosed with heart failure of ischemic etiology (either revascularized or cannot be revascularized);
- NYHA functional class II, III, or IVa (ambulatory);
- Left ventricular ejection fraction ≤ 35%;
- Subject wearing a prescribed ZOLL LifeVest WCD;
- Subject agrees to enter the Registry after appropriate informed consent.
Who cannot join
- Subjects who are unable or unwilling to cooperate with the study protocol;
- Subjects who are not willing to participate;
- Subjects who have acute ST-segment elevation myocardial infarction (STEMI) within 30 days before prescribed with WCD;
- Subjects with cardiomyopathy from mixed etiology;
- Subjects with active or previously explanted cardiac devices such as ICD, CRT or LVAD except for pacemaker;
- Subjects with a life expectancy of less than a year, including end-stage heart failure, cancer and end-stage renal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Prospective Registry of Patients With Ischemic Heart Failure Using the LifeVest Wearable Cardioverter Defibrillator (WEARIT-III)
The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.
Read the detailed description
STUDY PROCEDURE
U.S. patients prescribed a commercially available WCD (ZOLL LifeVest) will be approached by a letter from the sponsor which summarized the study purpose and procedure. Once a patient signs a consent form to participate the study, he or she will receive three questionnaire from University of Rochester, the coordination and data center for the WEARIT registry, at the time enrollment, at 3 month and 12 month follow-up, respectively. At 3 and 12-month follow-up, the physician of the patient will be contacted to provide information on arrhythmias, and interim events (ICD, CRT or LVAD implantation, heart failure episode, death), and to send us related hospital reports and echocardiogram reports to assess the improvement in left ventricular function.
STUDY DESIGN
WEARIT-III is a prospective observational patient registry. Optimal pharmacologic and/or implanted device therapy is anticipated, and the Registry physicians will not be involved in any medical care of the subjects, only collecting information on the standard care of these patients. In WEARIT-III we will also retrieve hospital records/echocardiogram reports of the subjects during follow-up using an authorization form signed by the study subjects and contact their physician to collect information on improvement of the left ventricular function whenever it is available.
DATA MANAGEMENT, DATA STORAGE
Once consented, device recordings and prescribing information will be obtained from the device provider. Data from the subject-completed questionnaire will also be obtained. Data will be entered into our web-based, password-protected clinical data-management system. That data will then be doubled-checked for accuracy by personnel working on the Registry. All study documents will be kept in a locked file room. All computers are password-protected and kept in a locked area.
DATA ANALYSIS
Routine patient clinical data as well as WCD data and clinical outcome during 1 year of follow-up will be recorded on all study patients and entered into a study-specific data- management system using our existing data management systems in the Heart Research Follow-up Program.
All analyses will be performed based on the primary and secondary objectives. Patient's clinical characteristics will be recorded and presented by descriptive statistics. Change in the clinical course will be recorded by descriptive statistics and compared to pre- WCD and post-WCD. Time-to-event analysis will be performed to assess the time until medication optimization. Clinical event will be presented as person-time rate and will be compared to previous WCD studies. Adverse events will be evaluated by raw counts and percentages. Compliance will be analyzed by mean and median of length of use and daily wear time.
- Conditions
- Ischemic Heart Failure
- Being tested
- LifeVest
- Keywords
- wearable cardioverter defibrillator, ischemic cardiomyopathy, new onset heart failure, sudden cardiac death
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeVestDevice
Also called Wearable Cardioverter Defibrillator WCD
LifeVest monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients with LifeVest | Subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator Receives: Device: LifeVest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinical events in heart failure patients with ischemic cardiomyopathy prescribed wearable cardioverter defibrillator (WCD)
The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with WCD, such as left ventricular function recovery, arrhythmia, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT), left ventricular assist device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.
Measured: 1 year
Secondary outcomes (4)
All-cause mortality
Evaluate the number of deaths and the cause of death in patients with ischemic cardiomyopathy and heart failure prescribed with WCD.
Measured: 1 year
Number of inappropriate shocks
Evaluate the safety of WCD in patients with ischemic cardiomyopathy and heart failure measured by the frequency of inappropriate WCD shocks
Measured: 1 year
WCD shock conversion success rate
Evaluate WCD shock efficacy measured by shock conversion success rate among WCD appropriate shocks
Measured: 1 year
NYHA functional class
Evaluate the NYHA functional class of heart failure patients with ischemic cardiomyopathy at enrollment, 3-month and 1-year after the initial prescription of the WCD in WEARIT-III
Measured: At enrollment, 3-month and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startJun 2014
- Primary completionFeb 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart FailureStudies 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
- 250 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Valentina Kutyifa, MD,PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700880
- Sponsor's protocol ID
- WEARIT-III
- Acronym
- WEARIT-III
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2016
- Last updated
- 28 Mar 2019
- 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 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Patients With Ischemic Heart Failure Using the LifeVest Wearable Cardioverter Defibrillator (WEARIT-III)
- ClinicalTrials.gov ID
- NCT02700880
- Acronym / sponsor ID
- WEARIT-III / WEARIT-III
- Conditions
- Ischemic Heart Failure
- Keywords
- wearable cardioverter defibrillator, ischemic cardiomyopathy, new onset heart failure, sudden cardiac death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- Jun 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 7 Mar 2016 (estimated)
- 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.
The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.
Detailed description
STUDY PROCEDURE
U.S. patients prescribed a commercially available WCD (ZOLL LifeVest) will be approached by a letter from the sponsor which summarized the study purpose and procedure. Once a patient signs a consent form to participate the study, he or she will receive three questionnaire from University of Rochester, the coordination and data center for the WEARIT registry, at the time enrollment, at 3 month and 12 month follow-up, respectively. At 3 and 12-month follow-up, the physician of the patient will be contacted to provide information on arrhythmias, and interim events (ICD, CRT or LVAD implantation, heart failure episode, death), and to send us related hospital reports and echocardiogram reports to assess the improvement in left ventricular function.
STUDY DESIGN
WEARIT-III is a prospective observational patient registry. Optimal pharmacologic and/or implanted device therapy is anticipated, and the Registry physicians will not be involved in any medical care of the subjects, only collecting information on the standard care of these patients. In WEARIT-III we will also retrieve hospital records/echocardiogram reports of the subjects during follow-up using an authorization form signed by the study subjects and contact their physician to collect information on improvement of the left ventricular function whenever it is available.
DATA MANAGEMENT, DATA STORAGE
Once consented, device recordings and prescribing information will be obtained from the device provider. Data from the subject-completed questionnaire will also be obtained. Data will be entered into our web-based, password-protected clinical data-management system. That data will then be doubled-checked for accuracy by personnel working on the Registry. All study documents will be kept in a locked file room. All computers are password-protected and kept in a locked area.
DATA ANALYSIS
Routine patient clinical data as well as WCD data and clinical outcome during 1 year of follow-up will be recorded on all study patients and entered into a study-specific data- management system using our existing data management systems in the Heart Research Follow-up Program.
All analyses will be performed based on the primary and secondary objectives. Patient's clinical characteristics will be recorded and presented by descriptive statistics. Change in the clinical course will be recorded by descriptive statistics and compared to pre- WCD and post-WCD. Time-to-event analysis will be performed to assess the time until medication optimization. Clinical event will be presented as person-time rate and will be compared to previous WCD studies. Adverse events will be evaluated by raw counts and percentages. Compliance will be analyzed by mean and median of length of use and daily wear time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients with LifeVest | – | Device: LifeVestSubjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In WEARIT-III, subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Cardioverter Defibrillator (WCD) and agree to enter the Registry after appropriate informed consent will be enrolled. It is anticipated that approximately 1000 patients with ischemic cardiomyopathy and heart failure (≥18 years of age) will be enrolled in 2 years. No individuals shall be excluded from participation in the Registry based on race, ethnicity or gender.
Key inclusion criteria (6 listed)
- Subjects of 18 years old or older;
- Subjects who are recently diagnosed with heart failure of ischemic etiology (either revascularized or cannot be revascularized);
- NYHA functional class II, III, or IVa (ambulatory);
- Left ventricular ejection fraction ≤ 35%;
- Subject wearing a prescribed ZOLL LifeVest WCD;
Key exclusion criteria (6 listed)
- Subjects who are unable or unwilling to cooperate with the study protocol;
- Subjects who are not willing to participate;
- Subjects who have acute ST-segment elevation myocardial infarction (STEMI) within 30 days before prescribed with WCD;
- Subjects with cardiomyopathy from mixed etiology;
- Subjects with active or previously explanted cardiac devices such as ICD, CRT or LVAD except for pacemaker;
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 |
|---|---|---|
| LifeVestAlso: Wearable Cardioverter Defibrillator WCDLifeVest monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. | Device | Heart failure patients with LifeVest |
Primary outcome
Number of clinical events in heart failure patients with ischemic cardiomyopathy prescribed wearable cardioverter defibrillator (WCD)
Time frame: 1 year
The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with WCD, such as left ventricular function recovery, arrhythmia, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT), left ventricular assist device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.
4 secondary outcomes
All-cause mortality
Time frame: 1 year
Number of inappropriate shocks
Time frame: 1 year
WCD shock conversion success rate
Time frame: 1 year
NYHA functional class
Time frame: At enrollment, 3-month and 1-year follow-up
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 28 Mar 2019.
- 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.
Valentina Kutyifa, MD,PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Failure, run by Zoll Medical Corporation at 1 site in United States.
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 6 inclusion and 6 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Number of clinical events in heart failure patients with ischemic cardiomyopathy prescribed wearable cardioverter defibrillator (WCD) (time frame: 1 year). 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 28 Mar 2019.