ACURATE TAVR System for Aortic Stenosis

Not currently recruiting at 76 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve, the ACURATE neo2 Transfemoral TAVR System, for treating severe aortic stenosis. This condition narrows the heart's aortic valve, causing symptoms like chest pain and shortness of breath. The trial compares this new valve with existing ones to assess its safety and effectiveness. Individuals diagnosed with severe aortic stenosis, experiencing symptoms that impact daily life, such as difficulty breathing during regular activities, may be suitable for this study. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that the ACURATE TAVR System is safe for transcatheter aortic valve replacement?

Research has shown that the ACURATE neo2 Transfemoral TAVR System is generally safe. In one study, 246 patients used this system, and only 5.1% passed away from any cause after one year, indicating that the treatment is usually well-tolerated. Another study found that the system performed well and remained safe for up to one year in regular medical settings.

For the ACURATE Prime Transfemoral TAVR System XL, early results from a human study showed no safety issues. No deaths or strokes were reported within 30 days after treatment. These findings suggest that both systems are safe options for patients with severe aortic stenosis considering transcatheter aortic valve replacement (TAVR). ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the ACURATE neo2™ Transfemoral TAVR System because it offers advancements in treating aortic stenosis, a condition where the heart's aortic valve narrows. Unlike standard treatments like the balloon-expandable SAPIEN 3 or self-expanding CoreValve systems, the ACURATE neo2™ aims to improve procedural efficiency and outcomes through its innovative design. Key features include its self-expanding technology that may offer enhanced valve positioning and sealing, potentially reducing complications such as leaks. Additionally, the transfemoral approach simplifies the procedure by accessing the heart through the femoral artery in the leg, which can be less invasive and allow for quicker recovery times. These innovations could make a significant difference for patients, particularly those who are at low risk.

What evidence suggests that this trial's treatments could be effective for aortic stenosis?

Research has shown that the ACURATE neo2 Transfemoral TAVR System, one of the treatments in this trial, effectively treats severe aortic stenosis, a condition where the heart valve doesn't open properly. Thirty days after the procedure, 79.2% of patients experienced little to no leakage around the new valve, with no cases of severe leakage. After one year, patients showed similar survival rates and health outcomes compared to those with other heart valves.

For the ACURATE Prime Transfemoral TAVR System XL, another treatment option in this trial, early studies have demonstrated its safety. Initial testing reported no deaths or strokes within 30 days, indicating the valve's safety and potential effectiveness. Both systems aim to help people with aortic stenosis by replacing the faulty heart valve without requiring open-heart surgery. ^{1 3 5 6 7}

Who Is on the Research Team?

Raj Makkar

Principal Investigator

Cedars-Sinai Heart Institute

Michael J. Reardon, MD

Principal Investigator

Methodist DeBakey Heart & Vascular Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1553838923006735

First results from the ACURATE Prime XL human feasibility ...

In this first-in-human feasibility study of the ACURATE Prime XL valve, there were no safety concerns, and no deaths or strokes within 30 days.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03735667

Study Details | NCT03735667 | ACURATE IDE: Safety and ...

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

3.

bostonscientific.com

bostonscientific.com/content/dam/bostonscientific/StructuralHeart/tavi-resources/sh-1376306-ad-acurate-publicationcompendium-digital.pdf

ACURATE™ Aortic Valve System Publication Compendium

Conclusions: One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Keywords: Aortic valve ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37429793/

First results from the ACURATE Prime XL human feasibility ...

In this first-in-human feasibility study of the ACURATE Prime XL valve, there were no safety concerns, and no deaths or strokes within 30 days.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05224245

ACURATE Prime XL Human Feasibility Study

To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects ...

6.

bostonscientific.com

bostonscientific.com/en-US/medical-specialties/structural-heart/acurate-clinical-data.html

ACURATE Clinical Data

Results: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were ...

7.

trialx.com

trialx.com/clinical-trials/listings/256182/acurate-ide-safety-and-effectiveness-study-of-acurate-valve-for-transcatheter-aortic-valve-replacement/

Safety and Effectiveness Study of ACURATE Valve for ...

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