Tetralogy of Fallot Clinical Trial
Official title:
Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent
| NCT number | NCT05378386 |
| Other study ID # | 2021-11 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 12, 2022 |
| Est. completion date | December 2034 |
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | December 2034 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: 1. Native or surgically-repaired RVOT with severe PR 2. Clinically indicated for pulmonary valve replacement 3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV Exclusion Criteria: 1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis or other active infections |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Schneider Children's Medical Center of Israel | Petah Tikva | |
| United States | Colorado Children's Hospital | Aurora | Colorado |
| United States | Children's of Alabama | Birmingham | Alabama |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | Medical City Dallas | Dallas | Texas |
| United States | Duke University | Durham | North Carolina |
| United States | Texas Children's Hospital | Houston | Texas |
| United States | Arkansas Children's Hospital | Little Rock | Arkansas |
| United States | Cedars Sinai Medical Center | Los Angeles | California |
| United States | Columbia University | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | Advocate Children's Hospital | Oak Lawn | Illinois |
| United States | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Washington University in St. Louis | Saint Louis | Missouri |
| United States | Primary Children's Hospital | Salt Lake City | Utah |
| United States | Rady's Children's Hospital | San Diego | California |
| United States | Seattle Children's Hospital | Seattle | Washington |
| United States | Stanford University | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Edwards Lifesciences |
United States, Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Acute Device Success | Acute Device Success, defined as a non-hierarchical composite of:
Single Alterra deployed in the desired location Single THV implanted in the desired location within Alterra Right ventricle-pulmonary artery peak-to-peak gradient < 35 mmHg post-THV implantation Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation |
24 hours post-procedure |
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