SAPIEN 3 THV for Pulmonary Valve Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the SAPIEN 3 Transcatheter Heart Valve (THV) System for effectiveness in individuals with specific heart valve issues. It targets those with a faulty right ventricular outflow tract (RVOT) conduit or a surgical valve in the pulmonic position requiring repair. Participants should have moderate to severe valve leakage or a significant blockage. The study aims to assess the effectiveness and safety of this new valve treatment for these heart conditions. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must be able to tolerate an anticoagulation or antiplatelet regimen, which might affect your current medication plan.
What prior data suggests that the SAPIEN 3 THV device is safe for use in the pulmonic position?
Research has shown that the SAPIEN 3 Transcatheter Heart Valve (THV) is generally well-accepted by patients. One study found that the valve performed well and produced positive health outcomes three years post-implantation. Specifically, 98.4% of patients were still alive after three years, indicating high survival rates. Another study reported no major safety issues up to six months after the procedure. However, some patients may be unable to take the necessary blood-thinning medication for this treatment. Overall, the SAPIEN 3 THV has demonstrated promising safety results for suitable candidates.12345
Why are researchers excited about this trial?
The SAPIEN 3 THV is unique because it allows for a less invasive procedure called transcatheter pulmonary valve replacement (TPVR) for those with a dysfunctional right ventricular outflow tract (RVOT) conduit or a previously implanted surgical valve in the pulmonic position. Unlike traditional open-heart surgery, which is the standard of care for these conditions, TPVR involves threading a catheter through the blood vessels to place the new valve, reducing recovery time and hospital stays. Researchers are excited about this treatment because it offers a quicker recovery, potentially lowers the risk of complications, and is specifically designed for patients who have undergone previous heart surgeries.
What evidence suggests that the SAPIEN 3 THV is effective for dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position?
Research has shown that the SAPIEN 3 Transcatheter Heart Valve (THV) System effectively treats heart valve problems. In one study, the valve functioned well in 98.5% of patients. After three years, 93.7% of patients did not require another procedure, and 97.1% did not develop endocarditis, a heart infection. The valve maintained good performance and results over three years. In this trial, participants with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR) using the SAPIEN 3 THV. These findings suggest the SAPIEN 3 THV is a reliable choice for those needing a valve replacement in the pulmonic position.24567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo transcatheter pulmonary valve replacement (TPVR) with the SAPIEN 3 THV System
Follow-up
Participants are monitored for device success and safety post-implantation
What Are the Treatments Tested in This Trial?
Interventions
- SAPIEN 3 THV
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD
Citations
3-Year Outcomes of the Edwards SAPIEN Transcatheter ...
Transcatheter pulmonary valve replacement using the Edwards SAPIEN THV demonstrates excellent valve function and clinical outcomes at 3-year follow-up.
3-Year Outcomes of the Edwards SAPIEN Transcatheter ...
Freedom from reintervention was 93.7% and from endocarditis was 97.1% at 3 years. There were no observed stent fractures. Conclusions.
Outcomes of transcatheter pulmonary SAPIEN 3 valve ...
Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months.
One-Year Clinical Outcomes With SAPIEN 3 Transcatheter ...
A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse ...
5.
edwards.com
edwards.com/healthcare-professionals/products-services/transcatheter-heart/transcatheter-sapien-3-valve-pulmonicTranscatheter pulmonary valve replacement
Deliver excellent outcomes, potentially delay reintervention, and improve quality of life for more of your patients. · References · Important Safety Information ...
FDA - Summary of Safety and Effectiveness Data
However, since transcatheter valve replacement with an Edwards SAPIEN 3. THV provides a less invasive alternative to surgical valve replacement, FDA believes.
Alterra Adaptive Prestent and SAPIEN 3 THV for ...
Device success was 100%. No staged procedures were necessary. No THV dysfunction was reported to 6 months. No serious safety signals were ...
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