Study 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.
Eligible Conditions
- Aortic Stenosis
Treatment Effectiveness
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Participants will be followed for the duration of the trial, through 10 years.
Year 1
Neurological status; National Institutes of Health Stroke Scale (NIHSS) Assessment
Year 1
Composite rate of all-cause mortality, all stroke, and rehospitalization at 1 year.
Year 5
Health Status; Kansas City Cardiomyopathy Quality of Life questionnaire Assessment
Health Status; SF-12 Quality of Life questionnaire Assessment
Year 5
Bleeding: life-threatening (or disabling) and major
Major vascular complications
Neurological status; Modified Rankin Scale (mRS) Assessment
Year 10
Mortality: all-cause, cardiovascular, and non-cardiovascular
Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
Number of Participants with hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
Number of participants with Ectopic valve deployment
Number of participants with Prosthetic aortic valve endocarditis
Number of participants with Prosthetic aortic valve thrombosis
Number of participants with Transcatheter aortic valve (TAV)-in-TAV deployment
Number of participants with Valve embolization
Number of participants with Valve migration
Number of participants with a repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Number of participants with new onset of atrial fibrillation or atrial flutter
Number of participants with new permanent pacemaker implantation resulting from new or worsened conduction disturbances
Stroke: disabling and non-disabling
Year 10
New York Heart Association (NYHA) Functional Status classification
Prosthetic aortic valve performance; Effective Orifice Area (EOA
Prosthetic aortic valve performance; Grade of Aortic Regurgitation
Prosthetic aortic valve performance; Mean Aortic Gradient
Prosthetic aortic valve performance; Peak Aortic Gradient
Prosthetic aortic valve performance; Peak Aortic Velocity
Day 7
Number of participants with Acute kidney injury (AKI; ≤7 days post index procedure): based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2
Year 10
Neurological status; Neurological physical exam assessment
Day 1
Grade of aortic valve regurgitation: paravalvular, central and combined (echocardiographic assessment)
Blood coagulation tests
Day 1
Number of participants with Device Success
Hour 72
Number of participants with Cardiac tamponade: periprocedural
Number of participants with Coronary obstruction: periprocedural
Number of participants with Mitral apparatus damage: periprocedural
Number of participants with Ventricular septal perforation
Trial Safety
Trial Design
4 Treatment Groups
Commercial Valve - Randomized
1 of 4
ACURATE Valve - Single-arm Prime XL
1 of 4
ACURATE Valve - Randomized
1 of 4
ACURATE Valve - Single-arm Roll-in
1 of 4
Active Control
Experimental Treatment
1720 Total Participants · 4 Treatment Groups
Primary Treatment: ACURATE neo2™ Transfemoral TAVR System · No Placebo Group · N/A
ACURATE Valve - Single-arm Prime XL
Device
Experimental Group · 1 Intervention: ACURATE Prime™ Transfemoral TAVR System XL · Intervention Types: DeviceACURATE Valve - Randomized
Device
Experimental Group · 1 Intervention: ACURATE neo2™ Transfemoral TAVR System · Intervention Types: DeviceACURATE Valve - Single-arm Roll-in
Device
Experimental Group · 1 Intervention: ACURATE neo2™ Transfemoral TAVR System · Intervention Types: DeviceCommercial Valve - RandomizedActiveComparator Group · 2 Interventions: Edwards SAPIEN 3 TAVR System, Medtronic CoreValve TAVR System · Intervention Types: Device, Device
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: participants will be followed for the duration of the trial, through 10 years.
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
674 Previous Clinical Trials
914,162 Total Patients Enrolled
Raj R. Makkar, MDPrincipal InvestigatorCedars-Sinai Heart Institute
Michael J. Reardon, MDPrincipal InvestigatorMethodist DeBakey Heart & Vascular Center
1 Previous Clinical Trials
1,746 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The heart team (composed of an experienced cardiac interventionalist and an experienced cardiac surgeon) has agreed that the subject is suitable for TAVR, likely to benefit from valve replacement, and this procedure is appropriate.
The subject (or their legal representative) acknowledges comprehension of the research demands and procedures, providing written informed consent.
All individuals participating in the study, their family members and/or legal representatives must agree to visit the hospital for any necessary follow up visits.
The subject is capable of undertaking the supplementary pharmacologic treatments mandated by the protocol.
You have severe aortic stenosis, evidenced by an AVA of ≤1.0 cm2 or AVA index ≤0.6 cm2/m2, mean pressure gradient ≥40 mmHg, maximal aortic valve velocity ≥4.0 m/s, and Doppler velocity index ≤ 0.25 as measured via echocardiography or hemodynamic testing.
You have an aortic annulus size between 21 mm and 29 mm, as confirmed by the Case Review Committee, that can be treated with a test or control device.
In cases of diminished aortic stenosis with deficient left ventricular functioning (ejection fraction <50%), dobutamine may be utilized to evaluate the seriousness of aortic stenosis (maximum permissible dose 20 mcg/kg/min advised); if echocardiographic criteria are satisfied through this stimulation, then subject enrollment is approved.
You have symptomatic aortic valve stenosis and are at least NYHA Functional Class II.
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Cancer Related
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