PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Merit Medical Systems, Inc.
Study ID
NCT06422871
Status
Recruiting
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Conditions

  • End Stage Renal Disease
  • Hemodialysis Access Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HeRO® Graft System or Super HeRO® System — DEVICE
    Treatment attempted with the HeRO® or Super HeRO® device.

Study Details

The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.

Key Dates

Start date
Jul 28, 2025
Status verified
May 2026
Primary completion
Jun 28, 2027
Completion
Dec 28, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: HeRO® / Super HeRO®
    Subjects who meet all inclusion criteria and none of the exclusion criteria and treatment is attempted with the HeRO® Graft or Super HeRO® device.

Primary Outcome Measure

Composite Endpoint [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Sarasota Memorial Health Care SystemSarasotaFlorida34239-
WakeMedRaleighNorth Carolina27610-
University Pittsburgh Medical CenterPittsburghPennsylvania15219-
Baylor Scott & White Heart and Vascular Hospital - DallasDallasTexas75226-
Houston Methodist HospitalHoustonTexas77030-
Sentara Norfolk General HospitalNorfolkVirginia23507-

Find similar trials in Washington D.C., DC

By research site
MedStar Washington Hospital Center· Washington D.C., DCSarasota Memorial Health Care System· Sarasota, FLWakeMed· Raleigh, NCUniversity Pittsburgh Medical Center· Pittsburgh, PABaylor Scott & White Heart and Vascular Hospital - Dallas· Dallas, TXHouston Methodist Hospital· Houston, TX

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