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Transcatheter Aortic Valve Replacement System

ACURATE TAVR System for Aortic Stenosis

N/A
Recruiting
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.)
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed for the duration of the trial, through 10 years.
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.
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My aortic annulus size is between 20.5 mm and 29 mm and suitable for treatment.
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A team of heart specialists agrees I should have a valve replacement via TAVR.
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I have symptoms from a narrowed heart valve and it affects my daily activities.
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I can visit the study hospital for all follow-ups and have consent.
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I can take the required additional medication for the study.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite rate of all-cause mortality, all stroke, and rehospitalization at 1 year in the Main Randomized Cohort.
Other outcome measures
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

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 - Main 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. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
Group VII: 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.

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Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
718 Previous Clinical Trials
930,128 Total Patients Enrolled
Michael J. Reardon, MDPrincipal InvestigatorMethodist DeBakey Heart & Vascular Center
1 Previous Clinical Trials
1,746 Total Patients Enrolled
Raj R. Makkar, MDPrincipal InvestigatorCedars-Sinai Heart Institute

Media Library

ACURATE neo2™ Transfemoral TAVR System (Transcatheter Aortic Valve Replacement System) Clinical Trial Eligibility Overview. Trial Name: NCT03735667 — N/A
Aortic Stenosis Research Study Groups: ACURATE Valve - Continued Access Study, Commercial Valve - Main Randomized, Commercial Valve - Extended Durability Randomized, ACURATE Valve - Extended Durability Randomized, ACURATE Valve - Main Randomized, ACURATE Valve - Single-arm Roll-in, ACURATE Valve - Single-arm Prime XL
Aortic Stenosis Clinical Trial 2023: ACURATE neo2™ Transfemoral TAVR System Highlights & Side Effects. Trial Name: NCT03735667 — N/A
ACURATE neo2™ Transfemoral TAVR System (Transcatheter Aortic Valve Replacement System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03735667 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this clinical trial at this time?

"Correct. Clinicaltrials.gov indicates that this medical trial is currently in need of participants, which was initially posted on June 10th 2019 and updated lastly November 28th 2022. This research requires 1670 individuals recruited from 77 separate sites."

Answered by AI

How many sites in the US are currently conducting this research?

"Recruitment for this trial is underway at 77 centres located in major cities such as Washington, Detroit and Charlotte. To reduce any potential inconveniences related to travel, it's best to choose the site nearest you if considering participation."

Answered by AI

How many participants are being included in this clinical trial?

"The trial's sponsor, the Boston Scientific Corporation, is seeking 1670 individuals who meet its criteria in order to conduct the study. This will take place at various locations such as Carolinas Medical Center in Charlotte and MedStar Washington Hospital Centre located within the District of Columbia."

Answered by AI
~0 spots leftby May 2024