Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01321073 · ClinicalTrials.gov registry record · NA
DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study
A NA study of Pulmonary Arterial Hypertension, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Active
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 8
- Study locations
NCT01321073: Active NA study of Pulmonary Arterial Hypertension, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01321073 is a NA study of Pulmonary Arterial Hypertension that is active but no longer recruiting, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 64 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01321073, a NA study of Pulmonary Arterial Hypertension, is active but no longer recruiting, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint.
Conditions Studied
Interventions
- DEVICE Model 10642 Implantable Intravascular Catheter
Study Locations (8)
Alabama
- University of Alabama at Birmingham - Birmingham
California
- VA Greater Los Angeles Healthcare System - Los Angeles
Florida
- AdventHealth Orlando - Orlando
Illinois
- University of Chicago Medical Center - Chicago
Massachusetts
- Brigham & Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Texas
- University of Texas Southwestern Medical Center - Dallas
Wisconsin
- Aurora St. Lukes Medical Center - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-06 |
| Est. Completion | 2032-12 |
| Phase | NA |
What the registry record for NCT01321073 still lists
NCT01321073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Model 10642 Implantable Intravascular Catheter is the first listed.
NCT01321073 lists 8 locations in 8 states (Alabama, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01321073 about?
NCT01321073 is a clinical study titled "DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study". 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 I...
What is the current status of trial NCT01321073?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 64 participants. The study started on 2011-06. Estimated completion is 2032-12.
What conditions does trial NCT01321073 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT01321073?
The interventions under investigation include: Model 10642 Implantable Intravascular Catheter (DEVICE).
Who is sponsoring clinical trial NCT01321073?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01321073 being conducted?
This trial has 8 study locations across Alabama, California, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Arterial Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01321073's enrollment target sits among peer trials
64 26th of 63 higher than 38 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
RECRUITING · NA
-
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study
RECRUITING · NA
-
Mobile Health Intervention to Improve Exercise in Pediatric PH
RECRUITING · NA
-
A Study of Pulmonary Hypertension Peripheral Limitations
RECRUITING · NA
-
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
RECRUITING · NA
-
Safety and Impact of Low Resistance Exercise Training on Quality of Life in Pulmonary Arterial Hypertension
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia