LVAD (Left Ventricular Assist Device)easiSLOW-LVADNCT07633561
Feasibility and Clinical Utility of Ambulatory Ultraslow Deflation Sphygmomanometers in LVAD Recipients - easiSLOW-LVAD Pilot
A study testing Ultraslow deflation cuff in people with LVAD (Left Ventricular Assist Device), run by University of Florida.
Trial summary
Prospective, single-arm feasibility study will evaluate the use of an ultraslow deflation automated sphygmomanometer (Terumo Elemano 2) for home BP monitoring in patients with continuous-flow LVADs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LVAD (Left Ventricular Assist Device)
- What is being tested?
- Ultraslow deflation cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Feb 2028
- 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
- HM3 LVAD and age > 18
Who cannot join
- eGFR < 30
- bilateral limb alerts (inability to obtain upper extremity blood pressures)
- ongoing inotropic support
- cognitive or severe visual impairment
- the use of an investigational LVAD
- Durable biventricular support
About this study
Prospective, single-arm feasibility study will evaluate the use of an ultraslow deflation automated sphygmomanometer (Terumo Elemano 2) for home BP monitoring in patients with continuous-flow LVADs. Outcomes include patient-reported ability to obtain BP readings, adherence, ease of use, and correlation with clinical parameters. Findings may support improved BP monitoring strategies in this high-risk population.
- Conditions
- LVAD (Left Ventricular Assist Device)
- Being tested
- Ultraslow deflation cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraslow deflation cuffDevice
Patients will be assigned to receive an ultraslow deflation syphgmomanometer for home blood pressure management
| Study group | Role | What they receive |
|---|---|---|
| Ultraslow deflation cuff | Other | Single arm interventional cohort Receives: Device: Ultraslow deflation cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to measure blood pressures
Successful BP measurement and recording
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LVAD (Left Ventricular Assist Device)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633561
- Sponsor's protocol ID
- IRB202600566
- Acronym
- easiSLOW-LVAD
- Status last verified
- Apr 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Clinical Utility of Ambulatory Ultraslow Deflation Sphygmomanometers in LVAD Recipients - easiSLOW-LVAD Pilot
- ClinicalTrials.gov ID
- NCT07633561
- Acronym / sponsor ID
- easiSLOW-LVAD / IRB202600566
- Conditions
- LVAD (Left Ventricular Assist Device)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
Prospective, single-arm feasibility study will evaluate the use of an ultraslow deflation automated sphygmomanometer (Terumo Elemano 2) for home BP monitoring in patients with continuous-flow LVADs. Outcomes include patient-reported ability to obtain BP readings, adherence, ease of use, and correlation with clinical parameters. Findings may support improved BP monitoring strategies in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultraslow deflation cuff | Other | Device: Ultraslow deflation cuffSingle arm interventional cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HM3 LVAD and age > 18
Key exclusion criteria (6 listed)
- eGFR < 30
- bilateral limb alerts (inability to obtain upper extremity blood pressures)
- ongoing inotropic support
- cognitive or severe visual impairment
- the use of an investigational LVAD
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 |
|---|---|---|
| Ultraslow deflation cuffPatients will be assigned to receive an ultraslow deflation syphgmomanometer for home blood pressure management | Device | Ultraslow deflation cuff |
Primary outcome
Ability to measure blood pressures
Time frame: 6 months
Successful BP measurement and recording
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 8 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraslow deflation cuff in people with LVAD (Left Ventricular Assist Device), run by University of Florida.
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 1 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Ability to measure blood pressures (time frame: 6 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 8 Jun 2026.