End Stage Renal DiseasePReSeRVE-HDNCT06422871
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
An observational study of End Stage Renal Disease and Hemodialysis Access Failure, run by Merit Medical Systems, Inc. at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis Access Failure
- What is being tested?
- HeRO® Graft System or Super HeRO® System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Jul 2025to 28 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-stage renal disease patients on hemodialysis who have exhausted all other access options.
Who may be able to join
- Subject provides written informed consent
- Subject is ≥ 18 years
- Subject is end-stage renal disease patient on hemodialysis.
- Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU)
Who cannot join
- Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement
- Subject has a topical or subcutaneous infection associated with the implantation site
- Subject has known or suspected systemic infection, bacteremia or septicemia
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Baylor Scott & White Heart and Vascular Hospital - Dallas
Dallas, Texas, 75226
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
- Recruiting
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
- Recruiting
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
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.
- Being tested
- HeRO® Graft System or Super HeRO® System
- Keywords
- HeRO
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeRO® Graft System or Super HeRO® SystemDevice
Treatment attempted with the HeRO® or Super HeRO® device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HeRO® Graft System or Super HeRO® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint
Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia
Measured: 6 months
Secondary outcomes (4)
Clinical Success
Measured: 12 and 24 months
Proportion of subjects with primary patency
Measured: 6, 12 and 24 months
Proportion of subjects with cumulative patency
Measured: 6, 12, and 24 months
Device-related safety events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start28 Jul 2025
- Primary completion28 Jun 2027 (estimated)
- Study completion28 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Hohmann, MD, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422871
- Sponsor's protocol ID
- CVO-P4-23-02
- Acronym
- PReSeRVE-HD
- Status last verified
- May 2026
- First submitted
- 15 May 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PReSeRVE-HD: PRospective, Multicenter, Observational Study of the Merit HeRO® Graft and Super HeRO® EValuated in End-Stage Renal Disease Patients on HemoDialysis
- ClinicalTrials.gov ID
- NCT06422871
- Acronym / sponsor ID
- PReSeRVE-HD / CVO-P4-23-02
- Keywords
- HeRO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 28 Dec 2028 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeRO® / Super HeRO® | – | Device: HeRO® Graft System or Super HeRO® SystemSubjects who meet all inclusion criteria and none of the exclusion criteria and treatment is attempted with the HeRO® Graft or Super HeRO® device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients on hemodialysis who have exhausted all other access options.
Key inclusion criteria (4 listed)
- Subject provides written informed consent
- Subject is ≥ 18 years
- Subject is end-stage renal disease patient on hemodialysis.
- Subject is treated with HeRO Graft or Super HeRO System in accordance with device instructions for use (IFU)
Key exclusion criteria (3 listed)
- Subject has a previously placed HeRO or Super HeRO device that is undergoing revision or replacement
- Subject has a topical or subcutaneous infection associated with the implantation site
- Subject has known or suspected systemic infection, bacteremia or septicemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeRO® Graft System or Super HeRO® SystemTreatment attempted with the HeRO® or Super HeRO® device. | Device | HeRO® / Super HeRO® |
Primary outcome
Composite Endpoint
Time frame: 6 months
Clinical Success, defined as maintenance of access circuit patency in the absence of device-related infection or bacteremia
4 secondary outcomes
Clinical Success
Time frame: 12 and 24 months
Proportion of subjects with primary patency
Time frame: 6, 12 and 24 months
Proportion of subjects with cumulative patency
Time frame: 6, 12, and 24 months
Device-related safety events
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Hohmann, MD principal investigator
Baylor Scott and White Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Hemodialysis Access Failure, run by Merit Medical Systems, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Susmeyer (978-758-6166, Hannah.Susmeyer@merit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.