Clinical Trials Logo
  1. Home
  2. End Stage Renal Disease
  3. NCT06422871
  4. Details
NCT06422871 Clinical Trial

Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

End Stage Renal Disease Clinical Trial

— PReSeRVE-HD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06422871
Other study ID # CVO-P4-23-02
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 15, 2025
Est. completion date July 15, 2028

Study information
Verified date May 2024
Source Merit Medical Systems, Inc.
Contact PReSeRVE-HD Clinical Affairs Team
Phone 978-758-6166
Email PReSeRVE-HDclinical@merit.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 175
Est. completion date July 15, 2028
Est. primary completion date January 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HeRO® Graft System or Super HeRO® System
Treatment attempted with the HeRO® or Super HeRO® device.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merit Medical Systems, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness Endpoint Proportion of subjects with cumulative patency 6 months
Primary Safety Endpoint Proportion of subjects with device-related infection-free survival 6 months
Secondary Proportion of subjects with primary patency 12 and 24 months
Secondary Proportion of subjects with cumulative patency 12 and 24 months
Secondary Device-related safety events 24 months
See also
  Status Clinical Trial Phase
Completed NCT04076488 - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases N/A
Completed NCT03289650 - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus Phase 3
Completed NCT04042324 - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients Phase 1/Phase 2
Completed NCT01242904 - Use of a Bimodal Solution for Peritoneal Dialysis Phase 2
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03257410 - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A
Withdrawn NCT02130817 - Belatacept in Kidney Transplantation of Moderately Sensitized Patients Phase 4
Completed NCT05540457 - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis) N/A
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Recruiting NCT02176434 - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease N/A
Active, not recruiting NCT02581449 - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis Phase 2
Completed NCT02830490 - Reliability of Functional Measures in Hemodialysis Patient. N/A
Completed NCT02832466 - Quantifying the Deterioration of Physical Function in Renal Patients N/A
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Completed NCT02215655 - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence N/A
Completed NCT02832440 - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis N/A
Recruiting NCT01912001 - Virtual Ward for Home Dialysis N/A