DelIVery for Pulmonary Arterial Hypertension (PAH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01321073
First received: March 21, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Pulmonary Arterial Hypertension
Device: The Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System to deliver Remodulin Injection

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Rate of catheter-related complications per 1000 patient days [ Time Frame: Baseline to 6 month visit ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: June 2011
Estimated Study Completion Date: January 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Device: The Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System to deliver Remodulin Injection
This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.

Detailed Description:

Pulmonary arterial hypertension (PAH) is a severe, chronic syndrome affecting the small pulmonary arteries (blood vessels which carry blood from the heart to the lungs to pick up oxygen). At the time of the initiation of this study, no cure exists for this disease. Medtronic has developed a fully implantable, long term, intravenous infusion system, which has the potential to enhance patient convenience and ease of use, while reducing the opportunities for catheter-related infections and complication issues associated with currently used external delivery systems. The information gained from this study could provide evidence to support use on an implantable infusion system for the management of other disease states requiring chronic intravenous therapy. Additionally, information collected from this study may contribute to the design of new product(s)/therapy(ies) and/or instructions for use.

The purpose of this clinical study is to evaluate the safety profile of the Model 10642 Implantable Intravascular Catheter portion of the PAH Implantable Vasodilator Therapy (PIVoT) system. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.

The Model 10642 Implantable Intravascular Catheter being used in this study is investigational, meaning it has not been approved by the FDA to be safe. The Model 10642 Catheter is different from other commercially available drug delivery catheters because the Model 10642 Catheter tube has a one-way valve designed to allow the medication to flow out but keep blood from flowing back into the catheter tube. The Model 10642 Catheter is reinforced to prevent kinking and crushing, which could interrupt the flow of medication.

Remodulin Injection is a Food and Drug Administration (FDA) approved drug for the intravenous and subcutaneous treatment of PAH.

The SynchroMed II Implantable Infusion System is approved by the FDA to deliver specific drugs in patients who have chronic pain, need management of severe spasticity, and for cancer treatment but has not been approved to deliver Remodulin Injection in patients with PAH.

There is also a Catheter Imaging Sub-Study that is being done to measure the shape change of the Model 10642 Implantable Intravascular Catheter during a given set of patient positions through the use of x-ray imaging. This data will help us develop more clinically realistic bench tests and simulations that better mimic the challenges experienced by an implanted catheter. This Catheter Imaging Sub-Study will be conducted at up to seven centers and will enroll up to forty patients that are currently enrolled in the DelIVery for PAH clinical study and are at least three months post-implant of their current catheter and pump.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is eighteen (18) years of age or older
  • Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
  • Patient is willing and able to comply with the protocol, including required follow-up visits
  • Patient is diagnosed with Pulmonary Arterial Hypertension (World Health Organization (WHO) Category Group 1 (by the WHO Clinical classification system)), including Idiopathic (IPAH), Heritable PAH (HPAH) (Familial PAH), and Associated with PAH (APAH), with exceptions as noted in exclusion criteria
  • Patient is receiving continuous infusion of Remodulin Injection therapy via intravenous delivery using an external drug delivery pump system. Patient has been at a stable Remodulin Injection dose (no change in dose) for at least four (4) weeks
  • Patient's anticoagulation therapy can be managed to permit safe device implantation
  • Patient has no history of pulmonary embolism since the initiation of subcutaneous or intravenous (IV) therapy for PAH

Exclusion Criteria:

  • Patient is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
  • Patient is enrolled, has participated within the last thirty (30) days, or is planning to participate, in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the Medtronic study manager that there is not a concern that co-enrollment could confound the results of this trial.
  • Patient has been initiated on a new oral PAH therapy in the last two (2) months
  • Patient has had a recent (within three (3) months) or otherwise unresolved infection requiring antibiotic treatment
  • Patient is diagnosed with PAH associated with hemoglobinopathies (sickle cell anemia, thalassemia), human immunodeficiency virus (HIV), schistosomiasis, portal hypertension, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
  • Patient is implanted with electrical stimulation medical device(s) anywhere in the body (e.g., cardiac pacemakers, implantable cardioverter defibrillators (ICDs), spinal cord stimulators). This includes implanted leads and electrodes or abandoned leads and electrodes from an explanted device
  • Patient is diagnosed with chronic kidney disease (serum creatinine greater than 2.5 milligrams per deciliter) within ninety (90) days prior to Baseline visit; chronic kidney disease is defined as that lasting or expected to last more than three (3) months.
  • Patient is a person for whom the implantable vascular catheter length of eighty (80) centimeters (cm) is excessively long or too short to be properly implanted
  • Patient has an existing external catheter(s) that would remain in place after the pump implant
  • Patient is a person for whom the implantable pump cannot be implanted two and a half (2.5) centimeters (cm) or less from the skin surface
  • Patient is a person whose body size is not sufficient to accept implantable pump bulk and weight
  • Patient is at increased susceptibility to systemic or soft tissue infections as determined by physician
  • Patient is Functional Class IV (New York Heart Association (NYHA))
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321073

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85012
United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Wisconsin
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, United States, 53234
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: DelIVery for PAH Clinical Research Specialist Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01321073     History of Changes
Other Study ID Numbers: PAH-D
Study First Received: March 21, 2011
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014