Feasibility and Clinical Utility of Ambulatory Ultraslow... | NCT07633561

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

NCT07633561

Sponsor

University of Florida

Status

Not yet recruiting

Last Update Posted

Jun 8, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

LVAD (Left Ventricular Assist Device)

Interventions

Ultraslow deflation cuff

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Aug 1, 2027Estimated

Completion Date

Feb 1, 2028Estimated

First Submitted Date

Jun 2, 2026

First Submission Date that Met QC Criteria

Jun 2, 2026

First Posted Date

Jun 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2026

Last Update Posted Date

Jun 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultraslow deflation cuff	Other	Single arm interventional cohort	Device: Ultraslow deflation cuff

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultraslow deflation cuff	Device	Patients will be assigned to receive an ultraslow deflation syphgmomanometer for home blood pressure management	Ultraslow deflation cuff

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to measure blood pressures	Successful BP measurement and recording	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided