## Protocol Section
### Identification Module
**NCT ID:** NCT06422871

**Acronym:** PReSeRVE-HD

**Brief Title:** Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

**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

#### Organization Study ID Info
**ID:** CVO-P4-23-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Merit Medical Systems, Inc.
### Status Module
#### Completion Date
**Date:** 2028-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-01-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-02-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merit Medical Systems, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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. Patients in the study will return to their study center 4 times over 2 years for follow-up visits to check their current health and dialysis status.

### Conditions Module

**Conditions:**

- End Stage Renal Disease

- Hemodialysis Access Failure

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 175

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: HeRO® Graft System or Super HeRO® System

**Label:** HeRO® / Super HeRO®

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HeRO® / Super HeRO®

**Description:** Treatment attempted with the HeRO® or Super HeRO® device.

**Name:** HeRO® Graft System or Super HeRO® System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Proportion of subjects with cumulative patency

**Measure:** Effectiveness Endpoint

**Time Frame:** 6 months

**Description:** Proportion of subjects with device-related infection-free survival

**Measure:** Safety Endpoint

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** Proportion of subjects with primary patency

**Time Frame:** 12 and 24 months

**Measure:** Proportion of subjects with cumulative patency

**Time Frame:** 12 and 24 months

**Measure:** Device-related safety events

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria:

* 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:

* 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** End-stage renal disease patients on hemodialysis who have exhausted all other access options.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** PReSeRVE-HDclinical@merit.com

**Name:** PReSeRVE-HD Clinical Affairs Team

**Phone:** 978-758-6166

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Baylor Scott and White Health

**Name:** Stephen Hohmann, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Renal Disease

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: End Stage Renal Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000007676

- Term: Kidney Failure, Chronic

### Misc Info Module

- Version Holder: 2024-05-31
