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Feasibility and Clinical Utility of Ambulatory Ultraslow Deflation Sphygmomanometers in LVAD Recipients - easiSLOW-LVAD Pilot

ConditionLVAD (Left Ventricular Assist Device)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HM3 LVAD and age > 18

Disqualifiers

eGFR < 30

bilateral limb alerts (inability to obtain upper extremity blood pressures)

ongoing inotropic support

cognitive or severe visual impairment

Trial design

Design model

Single group

Treatments tested in this trial

  • Ultraslow deflation cuff

    Device

    Patients will be assigned to receive an ultraslow deflation syphgmomanometer for home blood pressure management

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Ultraslow deflation cuffOther 1 intervention

Trial outcomes

Primary outcomes

1

Ability to measure blood pressures

Successful BP measurement and recording

Time frame
6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: