TAVI for Heart Valve Disease
(BASELINE Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Erasmus Medical Center
Disqualifiers: Multi-valve defects, Mechanical aortic valve, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses.
Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success.
Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro.
Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus.
Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO
Main study parameters/endpoints:
1. Primary endpoint is device success at 30 days
Defined by
* Absence of procedural mortality AND
* Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
* Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2
2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.
Do I need to stop my current medications for the TAVI trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Edwards Sapien S3/Ultra bioprosthesis and Evolut R/PRO bioprosthesis for heart valve disease?
Research shows that both the Edwards SAPIEN S3 and Medtronic Evolut R devices have high success rates for transcatheter aortic valve implantation (TAVI), with device success rates of over 90% and low 30-day mortality rates. Long-term outcomes are similar for both devices, with survival mainly influenced by other health conditions.
12345Is TAVI generally safe for humans?
Research shows that the Edwards Sapien S3 and Medtronic Evolut R valves used in TAVI are generally safe, with high device success rates and no significant differences in short-term complications like mortality or stroke between the two devices.
12367How does the TAVI treatment with Edwards Sapien S3/Ultra and Evolut R/PRO differ from other treatments for heart valve disease?
The TAVI treatment using Edwards Sapien S3/Ultra and Evolut R/PRO is unique because it involves a minimally invasive procedure to replace the heart valve without open-heart surgery, making it suitable for patients at high surgical risk. These newer-generation valves are designed to reduce complications like paravalvular leaks and vascular injuries, offering improved safety and outcomes compared to older valve systems.
15689Eligibility Criteria
This trial is for patients aged 65 or older with a failing surgical aortic bioprosthesis who need valve replacement and are eligible for transfemoral TAVI. They must be able to give informed consent and have been evaluated by a heart team using imaging techniques.Inclusion Criteria
I am 65 years old or older.
Written informed consent
My heart valve replacement is failing and I need a new one through a leg artery, as decided by my heart team.
Exclusion Criteria
I have had a stroke or a mini-stroke in the last month.
You have a blood clot in the left ventricle of your heart.
You have a mechanical aortic valve.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo transfemoral TAVI with either SAPIEN-3 / Ultra or Evolut R/Pro
1 day
1 visit (in-person)
Primary Endpoint Evaluation
Evaluation of device success at 30 days post-implantation
30 days
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness, including assessment of all-cause death, disabling stroke, and rehospitalization for heart failure or valve-related problems
1 year
Multiple visits (in-person and virtual)
Participant Groups
The study compares two types of transcatheter heart valves: the balloon-expandable Edwards Sapien S3/Ultra and the self-expanding Evolut R/PRO. It aims to determine which one has better device success at 30 days post-implantation in patients with degenerated bioprostheses.
2Treatment groups
Experimental Treatment
Active Control
Group I: Evolut R/Pro bioprosthesisExperimental Treatment1 Intervention
Study subjects will receive a self-expanding-valve (either the Evolut R or PRO device)
Group II: Edwards Sapien S3/Ultra bioprosthesisActive Control1 Intervention
Study subjects will receive a balloon-expanding-valve (either the Edwards Sapien S3 or Ultra)
Edwards Sapien S3/Ultra bioprosthesis is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Edwards Sapien S3/Ultra for:
- Severe aortic stenosis
- Degenerated aortic bioprostheses
🇺🇸 Approved in United States as Edwards Sapien S3/Ultra for:
- Severe aortic stenosis
- Degenerated aortic bioprostheses
🇨🇦 Approved in Canada as Edwards Sapien S3/Ultra for:
- Severe aortic stenosis
- Degenerated aortic bioprostheses
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars SinaiLos Angeles, CA
St Paul's and Vancouver General HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
Erasmus Medical CenterLead Sponsor
References
Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis. [2021]The 3rd generations of transcatheter heart valve system, including Edwards SAPIEN S3 (ES3) and Medtronic's Evolut R, has been developed to specifically improve the safety of transcatheter aortic valve implantation (TAVI). The aim of this work was to provide a summary effect estimate of the peri-procedural characteristics and clinical outcome of patients treated with ES3 versus the Evolut R.
Comparison of the Edwards SAPIEN S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation. [2022]New generation of the most widely used devices for transcatheter aortic valve implantation have been recently introduced into practice. We compare the short-term outcomes of transcatheter aortic valve implantation with the Edwards SAPIEN S3 and the Medtronic Evolut-R. We performed a retrospective analysis from a single high-volume tertiary center. Valve Academic Research Consortium-2 criteria were used to define composite end points of device success and safety at 30 days. Study population included 232 patients implanted with the SAPIEN S3 (n = 124) and Evolut-R (n = 108). Device success reached 91.9% and 95.4% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.289). Postprocedural echocardiography showed greater aortic valve gradients (22.8 ± 7 vs 16 ± 9 mm Hg, p
Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. [2020]Data on procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI) with the new-generation self-expanding Medtronic Evolut R prosthesis in comparison with its predecessor, the Medtronic CoreValve, are scarce. The aim of this study was to assess the safety and efficacy of the Evolut R device compared with the former-generation CoreValve.
Long-Term Outcome with New Generation Prostheses in Patients Undergoing Transcatheter Aortic Valve Replacement. [2021]The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014-2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p < 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications.
Current and future transcatheter aortic valve replacement valves. [2023]This review analyzes currently available commercial transcatheter aortic valve replacement (TAVR) valves as well as valves in investigational status and those in preclinical testing. The design features and clinical outcomes of the Edwards SAPIEN S3 and Medtronic Evolut PRO+ are described and compared with highlight clinical circumstances where one may be favoured over the other.
Meta-analysis of short- and long-term clinical outcomes of the self-expanding Evolut R/pro valve versus the balloon-expandable Sapien 3 valve for transcatheter aortic valve implantation. [2022]The Evolut R/Pro and the Sapien 3 are the most commonly valve systems used today for transcatheter aortic valve implantation (TAVI). However, there is a still uncertainty regarding the efficacy and safety comparison of these two valves.
Safety and efficacy of self-expandable Evolut R vs. balloon-expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta-analysis. [2020]The aim of this study was to systematically search literature and conduct a meta-analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66-1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83-3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = -3.96; 95% CI, -4.61 to -3.31; P<0.00001, I2=0%] and peak (random; MD = -6.85; 95% CI, -8.22 to -5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30-day mortality (OR, 1.32; 95% CI, 0.45-3.87; P=0.62; I2=0%) or 30-day stroke outcomes (OR, 0.76; 95% CI, 0.32-1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short-term complications. The differences between the 2 devices for post-operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi-center randomized controlled trial to provide stronger evidence on this subject.
Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. [2019]Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the balloon-expandable Edwards SAPIEN valve in patients deemed in-operable and at high-risk, and later on in intermediate-risk patients using the balloon-expandable SAPIEN-XT valve. These trials had laid the groundwork for advancements incorporated in the balloon-expandable SAPIEN-3 system such as the introduction of the anti-leak skirt and improved delivery system. In this review, we summarize the available data on the SAPIEN-3 transcatheter heart valve system and we highlight the special features of the newly designed self-expanding Edwards CENTERA valve, and the latest generation of balloon-expanable SAPIEN-3 Ultra™ system. A detailed literature search on these devices was undertaken using Ovid, PubMed, and Web of Science. Expert commentary: Data from clinical trials show that TAVI with newer-generation of Edwards transcatheter heart valve systems have shown significant improvement in terms of reduced paravalvular leak and have been associated with extremely good clinical outcomes.
The SAPIEN 3 valve: lights and shadows. [2014]Transcatheter aortic valve implantation (TAVI) has become an accepted alternative treatment option for high-risk or inoperable patients with symptomatic severe aortic stenosis. The future challenge for TAVI devices is to ensure results in terms of safety and efficacy that may justify an eligibility extension for this procedure to patients at intermediate and low risk for surgery. The ideal aortic valve prosthesis should be durable, with optimal hemodynamic performance and able to reduce the current major complications of TAVI procedure, in particular vascular complications (not infrequent with the transfemoral access route), paravalvular leaks, stroke and atrioventricular block requiring a permanent pacemaker. The SAPIEN 3™ (S3) (Edwards Lifesciences, Irvine, CA, USA) is the last Edwards family's transcatheter heart valves and incorporates a number of new and enhanced features intended to reduce the risk of vascular injury and paravalvular regurgitation, and to facilitate rapid and accurate positioning and implantation. The first data on S3 (SAPIEN3 trial) were presented at the EuroPCR 2014 and confirmed the advantage of the S3 compared with the previous Edwards valves (SAPIEN and SAPIEN XT) in terms of prevention of vascular complications and of moderate-severe paravalvular leaks, but showed an increase in the need of a permanent pacemaker post-TAVR. The S3 is certainly a promising evolution of transcatheter valves which may effectively reduce the risk of vascular complications and paravalvular leak. However, the S3 seems to be related to an increased risk of atrioventricular block, even if this complication could be due to the need to implant the valve in a higher position compared to previous models.