Suspended

ACURATE Device for Aortic Valve Replacement in TAVR Candidates

Study Aim

The study aims to evaluate the ACURATE device for aortic valve replacement in candidates for transcatheter aortic valve replacement by examining the rate of death, stroke, and rehospitalization one year after the procedure.

What is being tested

ACURATE neo2™ Transfemoral TAVR System

+ ACURATE Prime™ Transfemoral TAVR System XL

+ Medtronic CoreValve TAVR System

Device

Who is being recruted

Aortic Valve Disease+3

+ Aortic Valve Stenosis

+ Cardiovascular Diseases

+35 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2019

See protocol details

Summary

Principal SponsorBoston Scientific Corporation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 10, 2019

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new way to treat a condition where the heart's aortic valve becomes too narrow, making it hard for blood to flow through. The study involves a procedure called Transcatheter Aortic Valve Replacement (TAVR), which uses the ACURATE valve system. Participants in this study are patients who need this type of heart valve replacement. The trial aims to test the effectiveness and safety of the ACURATE valve compared to other types of valves already available, like the SAPIEN 3 and CoreValve systems. By evaluating these options, the trial hopes to find better ways to help patients with aortic valve stenosis, improving their heart function and overall quality of life. Participants in the study may receive one of several different valves, including the ACURATE valve, through a minimally invasive procedure. The study includes different groups of participants, some of whom will be randomly assigned to receive either the ACURATE valve or another standard valve. Participants are closely monitored over time, with regular check-ups shortly after the procedure, and then at regular intervals up to five years. The trial carefully measures results like survival, stroke occurrence, and the need for hospital visits due to heart issues. This information helps determine the best valve option, while ensuring the treatment is both effective and safe for patients.

Official TitleACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR

NCT03735667

Principal SponsorBoston Scientific Corporation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

1948 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseAortic Valve StenosisCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesVentricular Outflow Obstruction

Criteria

7 inclusion criteria required to participate

Subject has a documented aortic annulus size of ≥20.5 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the Main Randomized Cohort and the Extended Durability Study, is deemed treatable with an available size of both test and control device.

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.

For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.

Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate.

Show More Criteria

28 exclusion criteria prevent from participating

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

Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.

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.

Subject has hypertrophic cardiomyopathy.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

7 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 II

Experimental

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 III

Experimental

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

Experimental

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

Group 5

Active Comparator

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 6

Active Comparator

Group 7

Experimental

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 75 locations

Suspended

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps

Suspended

Banner Good Samaritan

Phoenix, United States

Suspended

University Hospitals of Cleveland

Cleveland, United States

Suspended

Cleveland Clinic

Cleveland, United States

Suspended75 Study Centers