NCT04860765

Brief Summary

This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
51mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Apr 2021Aug 2030

Study Start

First participant enrolled

April 13, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

9.3 years

First QC Date

April 23, 2021

Last Update Submit

January 30, 2026

Conditions

Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve DegenerationPulmonary Valve; Obstruction

Keywords

Transcatheter pulmonary valve replacementTranscatheter pulmonary valve implantationSAPIEN 3

Outcome Measures

Primary Outcomes (1)

  • Device Success

    Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient \< 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of explant at 24 hours post-implantation

    Discharge, expected to be within 1-5 days post-procedure

Study Arms (1)

TPVR

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Device: SAPIEN 3 THV

Interventions

SAPIEN 3 THVDEVICE

SAPIEN 3 THV in the pulmonic position

TPVR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention

You may qualify if:

  • Dysfunctional RVOT conduit or previously implanted surgical valve
  • RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

You may not qualify if:

  • Inability to tolerate an anticoagulation/antiplatelet regimen
  • Active bacterial endocarditis or other active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of Alabama

Birmingham, Alabama, 35487, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Advocate Childrens Hospital

Oak Lawn, Illinois, 60453, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Minneapolis Heart

Minneapolis, Minnesota, 55407, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinatti Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 19146, United States

Location

Dell Children's

Austin, Texas, 78723, United States

Location

Children's Health Dallas

Dallas, Texas, 75235, United States

Location

Primary Children's

Salt Lake City, Utah, 84108, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Pulmonary Valve InsufficiencyBites and Stings

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 27, 2021

Study Start

April 13, 2021

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(19)