Implantable System for Remodulin Post-Approval Study | NCT03833323

Studies
Implantable System for Remodulin Post-Approval Study

NCT03833323

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Status

Withdrawn

Last Update Posted

Jul 2, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Pulmonary Arterial Hypertension

Interventions

Implantable System for Remodulin (treprostinil)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Implantable System for Remodulin not commercially approved.

Expanded Access Info

Start Date

Aug 1, 2020Estimated

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Feb 5, 2019

First Submission Date that Met QC Criteria

Feb 5, 2019

First Posted Date

Feb 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2021

Last Update Posted Date

Jul 2, 2021Actual

Name	Class
United Therapeutics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.

Detailed Description

The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantable System for Remodulin (treprostinil)	Combination Product	All patients will be implanted with the Implantable System for Remodulin (treprostinil).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Catheter-related complications	Number of adverse events requiring invasive intervention that are related to the ISR catheter.	Implant to 5 years post-implant
Pump failures	Number of adverse events requiring invasive intervention that are related to the ISR pump.	Implant to 5 years post-implant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
Subject is intended to receive an eligible ISR product.
Subject is at least 22 years of age.

Exclusion Criteria:

Subject is pregnant.
Subject who is expected to be inaccessible for follow-up.
Subject with exclusion criteria required by local law.
Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Newly implanted patients that are intended to receive an ISR.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Robert Bourge, MD	University of Alabama at Birmingham	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C427248	treprostinil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided