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NCT Number: NCT07633561

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

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.

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Key information

Conditions

LVAD (Left Ventricular Assist Device)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HM3 LVAD and age > 18

Exclusion criteria

  • 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

Treatment and study plan

Ultraslow deflation cuff

Device

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

Primary outcomes

  1. Ability to measure blood pressures

    Time frame: 6 months

    Successful BP measurement and recording

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: easiSLOW-LVAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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