Pulmonary Arterial Hypertension
Conditions
Brief 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.
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.
Interventions
DEVICEModel 10642 Implantable Intravascular Catheter
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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
United Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study is observational and intended to provide ongoing support for the approximately 20 remaining subjects enrolled in the DelIVery for PAH Study including support of pump refills and system replacements. The study is expected to continue at the eight (8) remaining centers located in the United States that have current DelIVery for PAH study subjects enrolled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is currently enrolled in the DelIVery for PAH Study (G100017) * The physician and patient determine that continued use of the PIVoT system is medically advisable * Patient is willing to sign and date the Patient Informed Consent Form
Exclusion criteria
\- N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Catheter-related Complications Per 1000 Patient Days | Implant to 2 years | 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. |
Countries
United States
Contacts
STUDY_CHAIRDelIVery for PAH Clinical Research Specialist
Medtronic
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DelIVery for Pulmonary Arterial Hypertension Single Arm All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.
Model 10642 Implantable Intravascular Catheter: 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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | DelIVery for Pulmonary Arterial Hypertension Single Arm |
|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 13.5 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8 Participants |
| Race/Ethnicity, Customized White or Caucasian | 47 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 60 |
| other Total, other adverse events | 57 / 60 |
| serious Total, serious adverse events | 29 / 60 |
Outcome results
Primary
Rate of Catheter-related Complications Per 1000 Patient Days
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.
Time frame: Implant to 2 years
Population: All days of follow-up for implanted patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DelIVery for Pulmonary Arterial Hypertension Single Arm | Rate of Catheter-related Complications Per 1000 Patient Days | 0.27 complications per 1000 patient-days |
Comparison: The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.p-value: <0.00011-sample exact test for Poisson rate