ACURATE TAVR System for Aortic Stenosis

Recruiting at 74 trial locations

Overseen By Lisa Currier

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Antiplatelets

Must not be taking: Anticoagulants

Disqualifiers: Renal failure, Prosthetic valves, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: Peri-procedural and post-procedural up to discharge or 7 days post-procedure

1948 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to take the study's required medications, and you cannot have allergies to them.

What data supports the effectiveness of the ACURATE TAVR System for Aortic Stenosis treatment?

The ACURATE neo and neo2 valve systems have been shown to be effective alternatives to surgical valve replacement for aortic stenosis, with studies indicating their safety and performance in high-risk patients. The neo2 system, in particular, was designed to reduce the risk of leaks around the valve, and ongoing trials are evaluating its effectiveness across different patient risk categories. ^{1 2 3 4 5}

Is the ACURATE TAVR System safe for humans?

The ACURATE TAVR System, including the ACURATE neo and neo2 valves, has been studied in various clinical trials and real-world settings, showing it to be a generally safe option for patients with aortic stenosis. These studies have focused on its safety and performance, and the system has been used in Europe since 2014, with ongoing trials in the USA. ^{1 2 3 5 6}

What makes the ACURATE neo2™ Transfemoral TAVR System unique for treating aortic stenosis?

The ACURATE neo2™ Transfemoral TAVR System is unique because it is designed to be easier to implant and reduces the risk of paravalvular leak (a type of leakage around the valve) compared to earlier versions. It is a self-expanding device, which means it can adjust itself to fit the heart's anatomy better, potentially improving outcomes for patients with aortic stenosis. ^{1 3 4 5 7}

What is the purpose of this trial?

To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

Research Team

Raj Makkar

Principal Investigator

Cedars-Sinai Heart Institute

Michael J. Reardon, MD

Principal Investigator

Methodist DeBakey Heart & Vascular Center

Eligibility Criteria

This trial is for adults with severe aortic stenosis indicated for TAVR. Participants must have symptoms, be NYHA Class ≥ II, and agree to follow-up visits. They should have an aortic valve area ≤1.0 cm2 or other specific echocardiographic criteria and an annulus size of 20.5-29 mm. Exclusions include unicuspid/bicuspid valves, recent strokes, significant untreated coronary disease, cardiogenic shock, severe kidney/liver issues among others.

Inclusion Criteria

I have severe aortic stenosis confirmed by heart tests.

My aortic annulus size is between 20.5 mm and 29 mm and suitable for treatment.

A team of heart specialists agrees I should have a valve replacement via TAVR.

Exclusion Criteria

I need emergency surgery.

Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.

I have had endocarditis or a serious infection in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ACURATE Transfemoral Aortic Valve System or a comparator device for transcatheter aortic valve replacement

Peri-procedural and post-procedural up to discharge or 7 days post-procedure

In-person visits for procedure and immediate post-procedure monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Visits at 30 days, 6 months, and annually up to 10 years

Extended Durability Study

An additional randomized study for subjects at low surgical risk to assess long-term durability of the ACURATE valve

Long-term

Treatment Details

Interventions

• ACURATE neo2™ Transfemoral TAVR System
• ACURATE Prime™ Transfemoral TAVR System XL
• Edwards SAPIEN 3 TAVR System
• Medtronic CoreValve TAVR System

Trial Overview The study tests the safety and effectiveness of the ACURATE Transfemoral Aortic Valve System compared to existing systems like Medtronic CoreValve and Edwards SAPIEN 3 in patients with severe native aortic stenosis who are candidates for TAVR.

Participant Groups

Group I: ACURATE Valve - Single-arm Roll-in Experimental Treatment 1 Intervention

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.

Group II: ACURATE Valve - Single-arm Prime XL Experimental Treatment 1 Intervention

Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL. \*50 subjects will be enrolled in the Prime™ XL Nested Registry

Group III: ACURATE Valve - Main Randomized Experimental Treatment 1 Intervention

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. \*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.

Group IV: ACURATE Valve - Extended Durability Randomized Experimental Treatment 2 Interventions

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL. Only low risk patients are enrolled in this group.

Group V: ACURATE Valve - Continued Access Study Experimental Treatment 2 Interventions

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.

Group VI: Commercial Valve - Extended Durability Randomized Active Control 2 Interventions

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. Only low risk patients are enrolled in this group.

Group VII: Commercial Valve - Main Randomized Active Control 2 Interventions

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. \*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

In a study involving 89 patients with an average age of 83.7 years, the ACURATE neo transcatheter heart valve demonstrated a high procedural success rate of 94.4% and low rates of major complications, with a 30-day major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%.

At one year, the valve showed effective performance with only 4.5% of patients experiencing moderate paravalvular regurgitation, and a significant improvement in heart function, as indicated by a reduction in patients classified as NYHA Class III/IV from 94.4% at baseline to 4.5% at one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre "CE-approval cohort". Möllmann, H., Walther, T., Siqueira, D., et al.[2018]

The ACURATE neo aortic valve system is a self-expanding transcatheter device approved for treating severe aortic stenosis, showing wide clinical applicability since its CE mark in 2014.

Recent findings indicate that careful patient screening, size selection, and optimized positioning during implantation can significantly enhance the outcomes of using the ACURATE neo device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation with the ACURATE neo valve: indications, procedural aspects and clinical outcomes. Kim, WK., Hengstenberg, C., Hilker, M., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

The ACURATE neo™ and neo2™ Valve Systems. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre "CE-approval cohort". [2018]

3. France pubmed.ncbi.nlm.nih.gov

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation with the ACURATE neo valve: indications, procedural aspects and clinical outcomes. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The impact of learning-curve-experience on transcatheter aortic valve replacement outcomes: Insights from the United Kingdom and Ireland all-comers second-generation ACURATE neo™ transcatheter aortic heart valve registry. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2. [2023]