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Transcatheter Aortic Valve Replacement System

ACURATE TAVR System for Aortic Stenosis

N/A

Waitlist Available

Led By Michael J. Reardon, MD

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. (Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation.)

Must not have

Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.

Subject has a need for emergency surgery for any reason.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed for the duration of the trial, through 10 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include bleeding complications, vascular injury at access site, stroke or transient ischemic attack (TIA), irregular heart rhythms requiring pacemaker implantation after procedure; allergic reactions to materials or medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe aortic stenosis confirmed by heart tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart beats irregularly and cannot be slowed to less than 60 beats per minute.

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I need emergency surgery.

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

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My heart valve has one or two flaps.

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I have severe heart valve leakage.

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I need medication or devices to help my heart pump blood.

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I have been diagnosed with thickened heart muscles.

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I have severe dementia that greatly limits my daily activities.

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I haven't had a serious GI bleed or bleeding disorder in the last 3 months.

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I am allergic to certain contrast agents, aspirin, heparin, metals like nickel or titanium, or PET.

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My heart's mitral valve is significantly narrowed.

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I have a new heart clot or growth that needs treatment.

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I have severe heart or blood vessel conditions that make certain procedures unsafe.

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My heart's left ventricle is severely weak, with an ejection fraction under 20%.

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My kidney function is very low.

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I had a heart attack within the last 30 days.

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I am on dialysis or my kidney function is very low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed for the duration of the trial, through 10 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed for the duration of the trial, through 10 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed for the duration of the trial, through 10 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite rate of all-cause mortality, all stroke, and rehospitalization at 1 year in the Main Randomized Cohort.

Other study objectives

Bleeding: life-threatening (or disabling) and major

Grade of aortic valve regurgitation: paravalvular, central and combined (echocardiographic assessment)

Health Status; Kansas City Cardiomyopathy Quality of Life questionnaire Assessment

+31 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: ACURATE Valve - Single-arm Roll-inExperimental Treatment1 Intervention

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

Group II: ACURATE Valve - Single-arm Prime XLExperimental Treatment1 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 RandomizedExperimental Treatment1 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 RandomizedExperimental Treatment2 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 StudyExperimental Treatment2 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 RandomizedActive Control2 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 RandomizedActive Control2 Interventions

0 / 18Eligibility criteria met