DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study (NCT01321073)
DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical Study
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II Implantable Infusion System to deliver Remodulin® (treprostinil) Injection. As of June 2021, PMA approval of the Implantable System for Remodulin (ISR) is no longer being pursued and development and commercialization efforts have been halted. The approximately 30 subjects still implanted with the PIVoT system require a pathway for continued support. This protocol is amended and is designed to allow such ongoing support.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 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 (8 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- VA Greater Los Angeles Healthcare System — Los Angeles, California
- AdventHealth Orlando — Orlando, Florida
- University of Chicago Medical Center — Chicago, Illinois
- Brigham & Women's Hospital — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- University of Texas Southwestern Medical Center — Dallas, Texas
- Aurora St. Lukes Medical Center — Milwaukee, Wisconsin
💰 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 Pulmonary Arterial Hypertension
- A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION) — Aurora, Colorado
- A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension — Phoenix, Arizona
- Pulmonary Vascular Disease Phenomics Program PVDOMICS — Tucson, Arizona
- An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH) — Jacksonville, Florida
- A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension — Aurora, Colorado
- ADAPT - A Patient Registry of the Real-world Use of Orenitram® — Fresno, California
Explore by condition: All Pulmonary Arterial Hypertension 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.