Back to resultsCOMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Primary Purpose
Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAPIEN Transcatheter Valve Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Valve Insufficiency focused on measuring Pulmonic, Regurgitation, Pulmonary Valve Conduit, Stenosis, Congenital Heart Defect
Eligibility Criteria
Inclusion Criteria
- Weight must be equal to or exceed 35 kilograms.
- In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
- Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >= 35 mmHg by TTE.
- Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
- The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits.
- Catheterization is determined to be feasible by the treating physician.
Exclusion Criteria
- Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
- Previously enrolled in this study.
- Subject with pre-existing prosthetic heart valves in any position*.
- Severe chest wall deformity.
- Leukopenia (WBC<3000 mm3).
- Acute or chronic anemia (Hb <9 g/dL).
Sites / Locations
- Cedars-Sinai Medical Center
- Miami Children's Hospital
- Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)
- Rush Medical Center
- University of Michigan
- Children's Hospital of New York
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAPIEN THV
Arm Description
Outcomes
Primary Outcome Measures
Freedom From Device or Procedure Related Death or Reintervention
Secondary Outcome Measures
Freedom From MACCE
Clinical Events Committee (CEC) adjudicated.
Functional Improvement
Functional improvement at 6 months as defined by:
a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00676689
Brief Title
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Official Title
Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2008 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 31, 2019 (Actual)
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
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.
Detailed Description
The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Stenosis
Keywords
Pulmonic, Regurgitation, Pulmonary Valve Conduit, Stenosis, Congenital Heart Defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAPIEN THV
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SAPIEN Transcatheter Valve Implantation
Intervention Description
Device Implantation
Primary Outcome Measure Information:
Title
Freedom From Device or Procedure Related Death or Reintervention
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Freedom From MACCE
Description
Clinical Events Committee (CEC) adjudicated.
Time Frame
6 Months
Title
Functional Improvement
Description
Functional improvement at 6 months as defined by:
a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Weight must be equal to or exceed 35 kilograms.
In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >= 35 mmHg by TTE.
Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits.
Catheterization is determined to be feasible by the treating physician.
Exclusion Criteria
Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
Previously enrolled in this study.
Subject with pre-existing prosthetic heart valves in any position*.
Severe chest wall deformity.
Leukopenia (WBC<3000 mm3).
Acute or chronic anemia (Hb <9 g/dL).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziyad M Hijazi, M.D.
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Rush Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48130
Country
United States
Facility Name
Children's Hospital of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
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