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Not yet recruiting NCT07633561

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

No phase Interventional LVAD (Left Ventricular Assist Device)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultraslow deflation cuff.
Who it may be relevant to
Registry conditions: LVAD (Left Ventricular Assist Device). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Ultraslow deflation cuff
    Patients will be assigned to receive an ultraslow deflation syphgmomanometer for home blood pressure management

Primary outcome measures

  • Ability to measure blood pressures [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07633561 · IRB202600566

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗