Ignite Creation Date:
2024-05-05 @ 11:24 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01321073
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2011-03-21
Brief Title:
DelIVery for Pulmonary Arterial Hypertension PAH Continued Support Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
DelIVery for Pulmonary Arterial Hypertension PAH Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DelIVery
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
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 productstherapyies andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None