COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Pulmonary Valve Insufficiency Clinical Trial

Official title:

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02744677
• Other study ID #: 2015-01
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2016
• Est. completion date: June 2031

Study information

• Verified date: April 2024
• Source: Edwards Lifesciences
• Contact: Edwards THV Clinical Affairs
• Phone: (949) 250-2500
• Email: THV_CT.gov[@]Edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 2031
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Weight = 20 kg (44 lbs.)

2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter = 16.5 mm and = 29 mm immediately prior to study device insertion as per the Instructions for Use

3. Subject presents with at least moderate PR and/or mean RVOT gradient = 35 mmHg.

4. The subject/subject'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:

1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)

2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days

3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder

4. Inappropriate anatomy for femoral introduction and delivery of the study valve

5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty

6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)

7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.

8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.

9. History of or current intravenous drug use

10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year

11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications

12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated

13. Participating in another investigational drug or device study that has not reached its primary endpoint.

14. Female who is lactating or pregnant

Related Conditions & MeSH terms

• Complex Congenital Heart Defect
• Dysfunctional RVOT Conduit
• Heart Defects, Congenital
• Pulmonary Valve Degeneration
• Pulmonary Valve Insufficiency

Intervention

Device:
• SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
• SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position
• SAPIEN 3 Ultra RESILIA THV
SAPIEN 3 Ultra RESILIA THV in the pulmonic position

Locations

Country	Name	City	State
United States	Emory University/Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Childrens Hospital of Colorado	Aurora	Colorado
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Virginia (UVA)	Charlottesville	Virginia
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	The Lindner Research Center at Christ Hospital	Cincinnati	Ohio
United States	Children's Health System of Texas / UT Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Kentucky	Lexington	Kentucky
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	University of California, Los Angeles	Los Angeles	California
United States	LeBonheur Children's Hopsital	Memphis	Tennessee
United States	Intermountain Heart Institute (IMC)	Murray	Utah
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital	Saint Louis	Missouri
United States	University of California,, San Francisco (UCSF)	San Francisco	California
United States	University of Washington/Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lim DS, Kim D, Aboulhosn J, Levi D, Fleming G, Hainstock M, Sommer R, Torres AJ, Zhao Y, Shirali G, Babaliaros V. Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023 Mar 1;190:102-109. doi: 10.1016/j.amjcard.2022.12.010. Epub 2023 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	THV dysfunction	Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient > 40 mmHg via TTE	1 year
Secondary	Device Success	Defined as a composite of: 1) Single THV implanted in the desired location, 2) RV-PA peak-to-peak gradient < 35 mmHg post-implantation, 3) Less than moderate PR by discharge TTE (or earliest evaluable TTE), 4) Free of explant at 24 hours post-implantation.	Discharge, expected to be within 1-5 days post-procedure
Secondary	Mean RVOT gradient		6 months
Secondary	Paravalvular and total PR		6 months
Secondary	RVOT reintervention		6 months
Secondary	Coronary artery compression requiring intervention		30 days
Secondary	Major vascular complications		30 days
Secondary	Life-threatening or disabling bleeding		30 days
Secondary	THV frame fracture		6 months
Secondary	Device-related endocarditis		1 year
Secondary	Death (all-cause, procedural and device-related)		1 year