DelIVery for Pulmonary Arterial Hypertension (PAH)
- Interventional
- Active
- NCT01321073
Contact Information
DelIVery for Pulmonary Arterial Hypertension (PAH) Clinical 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 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.
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.
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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))
- 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))
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension