Heart FailureMultiVADNCT05388019
Multidisciplinary Ventricular Assist Device Clinic
A study testing Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) and Caregiver Self-Assessment in people with Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) and Caregiver Self-Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Ages 18+
- Individuals with ventricular assist device (VAD) implanted
- Individuals who have not previously attended standard-of-care VAD follow-up clinic visits
- Ages 18+
- Individuals with ventricular assist device (VAD) implanted
- Individuals who have previously attended standard-of-care VAD follow-up clinic visits
Who cannot join
- Inability to answer quality of life questionnaires
- Inability to perform the 6-minute walk test and Cardiopulmonary Exercise Test (CPET)
- Individuals who have previously attended standard-of-care VAD follow-up clinic visits
- Inability to answer quality of life questionnaires
- Inability to perform the 6-minute walk test and CPET
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Multidisciplinary Ventricular Assist Device Clinic: Feasibility Pilot Study and Quality of Life Impact Assessment
Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements.
This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients.
Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.
Read the detailed description
The current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is a mandated practice in the pre-implant and implant hospitalization phase of care. Each member of the MDT (surgeon, cardiologist, VAD coordinator, physical therapist, occupational therapist, social worker, and palliative care specialist) provides unique and orthogonal data. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Although patients are referred to cardiac rehabilitation post VAD implant, assessment of functional capacity improvement post-implant is not well standardized. In our program, PT, OT, SW and palliative care medicine do not routinely see patients at intervals post-implant and are available in a limited fashion if specific concerns arise.
Prior studies have shown that MDT care in VAD patients improves survival in an in-patient setting and proves to be feasible and effective in other disease processes. Despite major improvements in survival for VAD patients however, quality of life and physical functioning measures have not seen significant improvements. Since there is a clinical need to examine post-implant treatment, this study aims to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant.
This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.). This group will be matched with the prospective interventional patients. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Future work will study readmission rates, medical complications, and overall survival difference between MultiVAD clinic care and usual care VAD clinics.
Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. Newly-implanted VAD subjects will participate over a 24-month period and previously-implanted VAD subjects will participate over a 12-month period. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.
- Conditions
- Heart Failure
- Being tested
- Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires), Caregiver Self-Assessment
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)Other
Subject will receive care from a multidisciplinary team (physical therapy, occupational therapy, palliative care, social work) in addition to their standard of care VAD clinic visits. Subject will also perform a CPET, six-minute-walk-test, MoCA, and be administered quality of life questionnaires.
Caregiver Self-AssessmentBehavioural
Primary caregivers of both interventional VAD patient cohorts will be administered a Caregiver Self-Assessment to assess burnout.
| Study group | Role | What they receive |
|---|---|---|
| Prospective interventional cohort of newly-implanted patients | Experimental | This cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. Receives: Other: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) |
| Prospective interventional cohort of previously-implanted patients | Experimental | This cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. Receives: Other: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) |
| Retrospective control cohort | No intervention | The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.). |
| Primary caregiver cohort | Experimental | This cohort will consist of primary caregivers of VAD patients from the two interventional cohorts. They will be administered a questionnaire at two timepoints. Each VAD patient will be associated with only one primary caregiver for the duration of the study. Receives: Behavioral: Caregiver Self-Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise Test
Retrospective review in a patient chart.
Measured: Change from pre-implant peak VO2 at 12 months post LVAD implantation
Respiratory Exchange Ratio (RER) in % during Cardiopulmonary Exercise Test
Retrospective review in a patient chart.
Measured: Change from pre-implant RER at 12 months post LVAD implantation
Minute ventilation per carbon dioxide production (VE/VCO2) during Cardiopulmonary Exercise Test
Retrospective review in a patient chart.
Measured: Change from pre-implant VE/VCO2 at 12 months post LVAD implantation
Systolic and diastolic blood pressure in mmHg during Cardiopulmonary Exercise Test
Retrospective review in a patient chart.
Measured: Change from pre-implant blood pressure at 12 months post LVAD implantation
Heart rate in beats per minute during Cardiopulmonary Exercise Test
Retrospective review in a patient chart.
Measured: Change from pre-implant heart rate at 12 months post LVAD implantation
EuroQoL (EQ-5D and EuroVAS) to measure quality of life
Survey administered by research coordinator.
Measured: Change from pre-implant up to 12 months post LVAD implantation
Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life
Survey administered by research coordinator
Measured: Change from pre-implant up to 12 months post LVAD implantation
Montreal Cognitive Assessment (MoCA) to measure cognitive function
Assessment administered by Occupational Therapist
Measured: Change from pre-implant up to 12 months post LVAD implantation
Secondary outcomes (3)
Number of readmissions
Retrospective review in a patient chart
Measured: up to 24 months post-LVAD implantation
Time to readmission in days
Retrospective review in a patient chart
Measured: up to 24 months post-LVAD implantation
Number of VAD related complications
Retrospective review in a patient chart for GI bleed, CVA, heart failure, and infection
Measured: up to 24 months post-LVAD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start21 Apr 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Coglianese, Massachusetts General Hospital
- Investigators
- Erin Coglianese, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388019
- Sponsor's protocol ID
- 2021P00351
- Acronym
- MultiVAD
- Status last verified
- Dec 2025
- First submitted
- 11 May 2022
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tractenberg RE, Yumoto F, Aisen PS. Detecting When "Quality of Life" Has Been "Enhanced": Estimating Change in Quality of Life Ratings. Open J Philos. 2013 Nov 1;3(4A):24-31. doi: 10.4236/ojpp.2013.34A005.
PubMed 26213645
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Ventricular Assist Device Clinic: Feasibility Pilot Study and Quality of Life Impact Assessment
- ClinicalTrials.gov ID
- NCT05388019
- Acronym / sponsor ID
- MultiVAD / 2021P00351
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 May 2022 (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.
Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements.
This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients.
Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.
Detailed description
The current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is a mandated practice in the pre-implant and implant hospitalization phase of care. Each member of the MDT (surgeon, cardiologist, VAD coordinator, physical therapist, occupational therapist, social worker, and palliative care specialist) provides unique and orthogonal data. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Although patients are referred to cardiac rehabilitation post VAD implant, assessment of functional capacity improvement post-implant is not well standardized. In our program, PT, OT, SW and palliative care medicine do not routinely see patients at intervals post-implant and are available in a limited fashion if specific concerns arise.
Prior studies have shown that MDT care in VAD patients improves survival in an in-patient setting and proves to be feasible and effective in other disease processes. Despite major improvements in survival for VAD patients however, quality of life and physical functioning measures have not seen significant improvements. Since there is a clinical need to examine post-implant treatment, this study aims to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant.
This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.). This group will be matched with the prospective interventional patients. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Future work will study readmission rates, medical complications, and overall survival difference between MultiVAD clinic care and usual care VAD clinics.
Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. Newly-implanted VAD subjects will participate over a 24-month period and previously-implanted VAD subjects will participate over a 12-month period. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prospective interventional cohort of newly-implanted patients | Experimental | Other: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)This cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. |
| Prospective interventional cohort of previously-implanted patients | Experimental | Other: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)This cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. |
| Retrospective control cohort | No intervention | –The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.). |
| Primary caregiver cohort | Experimental | Behavioral: Caregiver Self-AssessmentThis cohort will consist of primary caregivers of VAD patients from the two interventional cohorts. They will be administered a questionnaire at two timepoints. Each VAD patient will be associated with only one primary caregiver for the duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18+
- Individuals with ventricular assist device (VAD) implanted
- Individuals who have not previously attended standard-of-care VAD follow-up clinic visits
- Ages 18+
- Individuals with ventricular assist device (VAD) implanted
Key exclusion criteria (5 listed)
- Inability to answer quality of life questionnaires
- Inability to perform the 6-minute walk test and Cardiopulmonary Exercise Test (CPET)
- Individuals who have previously attended standard-of-care VAD follow-up clinic visits
- Inability to answer quality of life questionnaires
- Inability to perform the 6-minute walk test and CPET
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 |
|---|---|---|
| Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)Subject will receive care from a multidisciplinary team (physical therapy, occupational therapy, palliative care, social work) in addition to their standard of care VAD clinic visits. Subject will also perform a CPET, six-minute-walk-test, MoCA, and be administered quality of life questionnaires. | Other | Prospective interventional cohort of newly-implanted patients, Prospective interventional cohort of previously-implanted patients |
| Caregiver Self-AssessmentPrimary caregivers of both interventional VAD patient cohorts will be administered a Caregiver Self-Assessment to assess burnout. | Behavioural | Primary caregiver cohort |
Primary outcome
Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise Test
Time frame: Change from pre-implant peak VO2 at 12 months post LVAD implantation
Retrospective review in a patient chart.
Respiratory Exchange Ratio (RER) in % during Cardiopulmonary Exercise Test
Time frame: Change from pre-implant RER at 12 months post LVAD implantation
Retrospective review in a patient chart.
Minute ventilation per carbon dioxide production (VE/VCO2) during Cardiopulmonary Exercise Test
Time frame: Change from pre-implant VE/VCO2 at 12 months post LVAD implantation
Retrospective review in a patient chart.
Systolic and diastolic blood pressure in mmHg during Cardiopulmonary Exercise Test
Time frame: Change from pre-implant blood pressure at 12 months post LVAD implantation
Retrospective review in a patient chart.
Heart rate in beats per minute during Cardiopulmonary Exercise Test
Time frame: Change from pre-implant heart rate at 12 months post LVAD implantation
Retrospective review in a patient chart.
EuroQoL (EQ-5D and EuroVAS) to measure quality of life
Time frame: Change from pre-implant up to 12 months post LVAD implantation
Survey administered by research coordinator.
Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life
Time frame: Change from pre-implant up to 12 months post LVAD implantation
Survey administered by research coordinator
Montreal Cognitive Assessment (MoCA) to measure cognitive function
Time frame: Change from pre-implant up to 12 months post LVAD implantation
Assessment administered by Occupational Therapist
3 secondary outcomes
Number of readmissions
Time frame: up to 24 months post-LVAD implantation
Time to readmission in days
Time frame: up to 24 months post-LVAD implantation
Number of VAD related complications
Time frame: up to 24 months post-LVAD implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 26213645Tractenberg RE, Yumoto F, Aisen PS. Detecting When "Quality of Life" Has Been "Enhanced": Estimating Change in Quality of Life Ratings. Open J Philos. 2013 Nov 1;3(4A):24-31. doi: 10.4236/ojpp.2013.34A005.
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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.
Erin Coglianese, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires) and Caregiver Self-Assessment in people with Heart Failure, run by Massachusetts General Hospital 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 5 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: enrolling by invitation, as of the sponsor's last update on 30 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise Test (time frame: Change from pre-implant peak VO2 at 12 months post LVAD implantation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388019, which also lists 1 linked publication.
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 30 Dec 2025.