SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy (NCT03924661)
A Single Arm, Non-randomized, Multi-center Clinical Study of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
🩺 Plain-English Summary (8th-Grade Level)
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles (USC) — Los Angeles, California
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Children's Hospital Los Angeles (USC) — Los Angeles, California
- Valley Children's Hospital — Madera, California
- Sutter Medical Center, Sacramento — Sacramento, California
- Variety Children's Hospital — Miami, Florida
- Children's Healthcare of Atlanta — Atlanta, Georgia
- University of Mississippi Medical Center — Jackson, Mississippi
- Cincinnati Children's Hospital — Cincinnati, Ohio
- Dell Children's Medical Center — Austin, Texas
- Children's Medical Center Dallas — Dallas, Texas
- Sana - Herzchirurgische Klinik Stuttgart GmbH — Stuttgart, Baden-Wurttemberg
- Deutsches Herzzentrum München des Freistaates Bayern — München, Bavaria
- Herzzentrum Leipzig GmbH — Leipzig, Saxony
- Medizinische Hochschule Hannover — Hanover,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Aortic Valve Disease
- Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP) — Danville, Pennsylvania
- Early Feasibility Study for the Foldax Tria Aortic Heart Valve — Indianapolis, Indiana
- Avalus Ultra Post-Approval Study (PAS) — Hartford, Connecticut
- J-Valve TF Early Feasibility Study — Scottsdale, Arizona
- Valved Graft PMCF Study — Birmingham, Alabama
Explore by condition: All Aortic Valve Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.