SAPIEN X4 THV for Failing Aortic Valves
Recruiting in Palo Alto (17 mi)
+33 other locations
Overseen byTamim M. Nazif, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Edwards Lifesciences
Disqualifiers: Severe mitral regurgitation, Renal insufficiency, Stroke, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new artificial heart valve that can be inserted without open-heart surgery. It focuses on high-risk patients with failing aortic valves. The valve is placed using a thin tube, making the procedure safer for these patients. This new method offers a less invasive alternative to conventional surgery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants must be able to tolerate antithrombotic therapy (medications that prevent blood clots).
What data supports the effectiveness of the SAPIEN X4 THV treatment for failing aortic valves?
The SAPIEN 3 valve, a similar treatment, has shown good outcomes in patients with severe aortic stenosis, a condition where the heart's aortic valve narrows, making it hard for blood to flow. This suggests that the SAPIEN X4 THV might also be effective for failing aortic valves.
12345Is the SAPIEN X4 THV generally safe for humans?
The Edwards SAPIEN transcatheter heart valve, a predecessor to the SAPIEN X4, has been reviewed for safety in high-risk patients with aortic stenosis, and the benefits were found to outweigh the risks. It has been approved by the FDA for use in patients who are not suitable for surgery, indicating a level of safety in human use.
13678What makes the SAPIEN X4 THV treatment unique for failing aortic valves?
The SAPIEN X4 THV is a transcatheter heart valve that offers a minimally invasive option for patients with failing aortic valves, potentially reducing the need for open-heart surgery. It builds on previous versions like the SAPIEN 3 by incorporating features to minimize complications such as aortic regurgitation (leakage of blood back into the heart) and improve the accuracy of valve placement.
1591011Eligibility Criteria
This trial is for adults with a failing aortic bioprosthetic valve who are at high surgical risk. They must have symptoms of heart dysfunction (NYHA class ≥ II) and be suitable for the SAPIEN X4 THV based on their valve size. Participants need to consent to study provisions. Exclusions include unstable valves, severe mitral issues, blood disorders, recent major cardiac events or procedures, pregnancy, certain anatomical features that complicate the procedure, active COVID-19 infection or related sequelae.Inclusion Criteria
You have a bioprosthetic valve that is the right size for the SAPIEN X4 THV.
You have heart problems that make it difficult for you to do daily activities.
Heart Team agrees the subject is at high or greater surgical risk
+2 more
Exclusion Criteria
My heart valve replacement doesn't work well, causing high blood pressure in my heart.
The heart valve is not working properly or is damaged.
I am scheduled for a procedure to treat atrial fibrillation.
+29 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN X4 Transcatheter Heart Valve
Immediate procedure
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the TAVR procedure
1 year
Multiple visits (in-person and virtual)
Participant Groups
The Edwards SAPIEN X4 Transcatheter Heart Valve (THV) is being tested for safety and effectiveness in patients with failing aortic bioprosthetic valves who face high risks from traditional surgery. The study will evaluate how well this new device works as an alternative to replace dysfunctional heart valves without open-heart surgery.
2Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR) - THVExperimental Treatment1 Intervention
TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).
Group II: Transcatheter Aortic Valve Replacement (TAVR) - Surgical ValveExperimental Treatment1 Intervention
TAVR implant in subjects with a failing aortic surgical valve.
SAPIEN X4 THV is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as SAPIEN X4 THV for:
- Severe aortic stenosis in patients at high risk for surgical complications
- Failing aortic bioprosthetic valves
🇪🇺 Approved in European Union as SAPIEN X4 THV for:
- Severe aortic stenosis in patients at high risk for surgical complications
- Failing aortic bioprosthetic valves
🇨🇦 Approved in Canada as SAPIEN X4 THV for:
- Severe aortic stenosis in patients at high risk for surgical complications
- Failing aortic bioprosthetic valves
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novant Health and Vascular InstituteCharlotte, NC
St. Paul's Hospital VancouverVancouver, Canada
Hoag Memorial Hospital PresbyterianNewport Beach, CA
Kaiser San FranciscoSan Francisco, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Edwards LifesciencesLead Sponsor
References
Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial. [2021]To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk.
Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes. [2022]The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial.
Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. [2013]The Edwards SAPIEN transcatheter heart valve (THV) is approved for aortic stenosis patients considered inoperable because of high surgical risk. Based on the high-risk arm of the PARTNER trial, the Food and Drug Administration's Circulatory System Devices Panel reviewed an additional indication for use in high-risk, operable patients. Although several concerns were raised regarding safety, trial misconduct, and several subgroup analyses, most panel members agreed that the Edwards SAPIEN THV (Edwards Lifesciences LLC, Irvine, CA), when used in high-risk patients, is noninferior to surgical aortic valve replacement. The panel voted 11 to 0 (with 1 abstention) that the benefits of the Edwards SAPIEN THV do outweigh the risks for use in the indicated patient population. This summary aims to describe the discussions and recommendations made during the meeting. Based on the panel recommendation, the device was approved by the Food and Drug Administration.
Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. [2022]Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.
Impact of post-implant SAPIEN XT geometry and position on conduction disturbances, hemodynamic performance, and paravalvular regurgitation. [2014]This report sought to study the impact of the balloon-expandable SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve (THV) stent frame geometry and position on outcomes of transcatheter aortic valve replacement (TAVR).
A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. [2022]The purpose of this study was to determine the safety and effectiveness of the SAPIEN XT versus SAPIEN systems (Edwards Lifesciences, Irvine, California) in patients with symptomatic, severe aortic stenosis (AS) who were not candidates for surgery.
2012 update on the Edwards SAPIENTM transcatheter heart valve. [2018]Last year was the 10th anniversary of the first transcatheter aortic valve implantation (TAVI) performed by Alain Cribier using the Cribier-Edwards transcatheter heart valve (THV). The Edwards SAPIENTM THV (Edwards Lifesciences, Irvine, CA, USA) was the first commercially available balloon-expandable THV to receive CE-Mark certification in Europe for transfemoral and transapical aortic valve implantation in 2007/2008. Outcome of the prospective randomized PARTNER-US trial resulted in FDA approval for TAVI using the Edwards SAPIENTM THV in patients unsuitable for surgery in 2011 and high-risk patients in 2012. This experience, together with results from the SOURCE Registry and National Registries, has resulted in further modifications of valve design and delivery systems, but also improvement in patient selection and procedural techniques. In this manuscript we review the changes made to the newest model of the Edwards SAPIENTM and its delivery systems over time with an emphasis on the SAPIEN XTTM. We also summarize the recent experience presented on the Edwards SAPIENTM and SAPIEN XTTM, new access routes and lessons learned for patient assessment, as well as opportunities for future development of the device.
Transaortic transcatheter aortic valve implantation: experience from the Kiel study. [2018]To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access.
Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. [2022]The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic valve replacement (TAVR). An ultra-low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation.
Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison. [2016]The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis.
Long-term outcomes and prosthesis performance after transcatheter aortic valve replacement: results of self-expandable and balloon-expandable transcatheter heart valves. [2020]Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES.