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

Primary Purpose

Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
SAPIEN 3 THV
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Congenital Heart Defect focused on measuring Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Pulmonary Atresia, Pulmonary Stenosis, Truncus Arteriosus, Transposition of the Great Arteries, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, TPV, TPVR, TPVI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 SAPIEN 3 THV
  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. Emergency 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. Currently participating in an investigational drug or another device study.
  14. Positive urine or serum pregnancy test in female subjects of child-bearing potential

Sites / Locations

  • University of California, Los AngelesRecruiting
  • University of California,, San Francisco (UCSF)Recruiting
  • Emory University/Children's Healthcare of AtlantaRecruiting
  • University of Kentucky
  • Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
  • Columbia University Medical Center/NYPHRecruiting
  • Duke University Medical CenterRecruiting
  • The Lindner Research Center at Christ HospitalRecruiting
  • Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of PhiladelphiaRecruiting
  • Intermountain Heart Institute (IMC)Recruiting
  • University of Virginia (UVA)Recruiting
  • University of Washington/Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

TPVR - Main Cohort

TPVR - THV Registry

TPVR- S3UR Registry

Arm Description

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

Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Mean RVOT gradient
Paravalvular and total PR
RVOT reintervention
Coronary artery compression requiring intervention
Major vascular complications
THV frame fracture
Device-related endocarditis
Death (all-cause, procedural and device-related)

Full Information

First Posted
April 12, 2016
Last Updated
April 26, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT02744677
Brief Title
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Official Title
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
Keywords
Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Pulmonary Atresia, Pulmonary Stenosis, Truncus Arteriosus, Transposition of the Great Arteries, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, TPV, TPVR, TPVI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPVR - Main Cohort
Arm Type
Experimental
Arm Description
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
Arm Title
TPVR - THV Registry
Arm Type
Experimental
Arm Description
Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
Arm Title
TPVR- S3UR Registry
Arm Type
Experimental
Arm Description
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
Intervention Type
Device
Intervention Name(s)
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
Intervention Description
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Intervention Type
Drug
Intervention Name(s)
SAPIEN 3 THV
Intervention Description
SAPIEN 3 THV in the pulmonic position
Primary Outcome Measure Information:
Title
THV dysfunction
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Device Success
Description
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.
Time Frame
Discharge, expected to be within 1-5 days post-procedure
Title
Mean RVOT gradient
Time Frame
6 months
Title
Paravalvular and total PR
Time Frame
6 months
Title
RVOT reintervention
Time Frame
6 months
Title
Coronary artery compression requiring intervention
Time Frame
30 days
Title
Major vascular complications
Time Frame
30 days
Title
THV frame fracture
Time Frame
6 months
Title
Device-related endocarditis
Time Frame
1 year
Title
Death (all-cause, procedural and device-related)
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Weight ≥ 20 kg (44 lbs.) 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 Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg. 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: Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics) History of or active endocarditis (active treatment with antibiotics) within the past 180 days Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder Inappropriate anatomy for femoral introduction and delivery of the study valve 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 Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI) Interventional/surgical procedures within 30 days prior to the TPVI procedure. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure. History of or current intravenous drug use Major or progressive non-cardiac disease resulting in a life expectancy of less than one year Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated Participating in another investigational drug or device study that has not reached its primary endpoint. Female who is lactating or pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edwards THV Clinical Affairs
Phone
(949) 250-2500
Email
THV_CT.gov@Edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Scott Lim, MD
Organizational Affiliation
University of Virginia Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vasilis Babaliaros, MD
Organizational Affiliation
Emory University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California,, San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University/Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Withdrawn
Facility Name
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Completed
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
The Lindner Research Center at Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Intermountain Heart Institute (IMC)
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia (UVA)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington/Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36608435
Citation
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.
Results Reference
background

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

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