COMPASSION XT PAS - Post-approval Study of the SAPIEN XT... | NCT02987387

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2017Actual

Primary Completion Date

Aug 9, 2021Actual

Completion Date

Sep 30, 2025Actual

First Submitted Date

Oct 19, 2016

First Submission Date that Met QC Criteria

Dec 6, 2016

First Posted Date

Dec 8, 2016Estimated

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

Dec 12, 2025

Last Update Posted Date

Dec 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

Detailed Description

The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.

Conditions Module

Conditions

Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Heart Diseases

Keywords

Tetralogy of Fallot
Aortic Valve Defect/Disease Resulting in Ross Procedure
Transcatheter pulmonary valve implantation
Transcatheter pulmonary valve replacement
Pulmonary Atresia
Pulmonary Stenosis

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

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TPVI		Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV	Device: SAPIEN XT THV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAPIEN XT THV	Device	SAPIEN XT THV will be implanted in the pulmonic position.	TPVI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom from device- or procedure-related death or reintervention		1 year

Secondary Outcomes

Measure	Description	Time Frame
Decrease in pulmonary regurgitation to mild or less for regurgitant lesions	Assessed via transthoracic echocardiogram (TTE)	1 year
Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient has a dysfunctional, non-compliant RVOT conduit.
The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

Inability to tolerate an anticoagulation/antiplatelet regimen
Active bacterial endocarditis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama		Birmingham	Alabama	35294	United States
Children's Hospital Colorado

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D011665	Pulmonary Valve Insufficiency
D011666	Pulmonary Valve Stenosis
D006330	Heart Defects, Congenital
D000013	Congenital Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D013771	Tetralogy of Fallot
D000082862	Aortic Valve Disease
D018633	Pulmonary Atresia

ID	Term
D006349	Heart Valve Diseases
D014694	Ventricular Outflow Obstruction
D018376	Cardiovascular Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D054079	Vascular Malformations