NCT07633561

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

LVAD (Left Ventricular Assist Device)

Outcome Measures

Primary Outcomes (1)

  • Ability to measure blood pressures

    Successful BP measurement and recording

    6 months

Study Arms (1)

Ultraslow deflation cuff

OTHER

Single arm interventional cohort

Device: Ultraslow deflation cuff

Interventions

Ultraslow deflation cuffDEVICE

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

Ultraslow deflation cuff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HM3 LVAD and age \> 18

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-04