ACURATE TAVR System for Aortic Stenosis

Recruiting at 74 trial locations

Overseen By Lisa Currier

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Trial Summary

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.

Treatment Details

Interventions

• ACURATE neo2™ Transfemoral TAVR System (Transcatheter Aortic Valve Replacement System)
• ACURATE Prime™ Transfemoral TAVR System XL (Transcatheter Aortic Valve Replacement System)
• Edwards SAPIEN 3 TAVR System (Transcatheter Aortic Valve Replacement System)
• Medtronic CoreValve TAVR System (Transcatheter Aortic Valve Replacement 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