Cardiovascular Diseases Clinical Trial
Official title:
New Enrollment SAPIEN XT Post-Approval Study
Verified date | October 2023 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 57 |
Est. completion date | September 2025 |
Est. primary completion date | August 9, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Patient has a dysfunctional, non-compliant RVOT conduit. 2. 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: 1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | University of Alabama | Birmingham | Alabama |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | The University of Iowa | Iowa City | Iowa |
United States | Children's Heart Center Nevada | Las Vegas | Nevada |
United States | Mount Sinai Beth Israel | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Advocate Children's Hospital | Oak Lawn | Illinois |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from device- or procedure-related death or reintervention | 1 year | ||
Secondary | Decrease in pulmonary regurgitation to mild or less for regurgitant lesions | Assessed via transthoracic echocardiogram (TTE) | 1 year | |
Secondary | Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions | Assessed via TTE | 1 year | |
Secondary | Device Success | Device Success is a composite of:
Deployment of the valve to the target area, and Removal of the delivery catheter out of the body, and Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE. |
48 Hours Prior to Discharge |
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