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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.)
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 belowSelect...
I have severe aortic stenosis confirmed by heart tests.
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.
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 moreTrial 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
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.
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
930,250 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need emergency surgery.I have had endocarditis or a serious infection in the last 6 months.I have severe aortic stenosis confirmed by heart tests.My heart valve has one or two flaps.My aortic annulus size is between 20.5 mm and 29 mm and suitable for treatment.My heart beats irregularly and cannot be slowed to less than 60 beats per minute.I have severe heart valve leakage.I will be on long-term blood thinner treatment after my procedure.I have heart artery disease that needs treatment according to my doctor.I need medication or devices to help my heart pump blood.A team of heart specialists agrees I should have a valve replacement via TAVR.Your blood platelet count is very low or very high, or your white blood cell count is very low.I haven't had any heart or blood vessel procedures in the last 30 days, except for specific allowed treatments.I have been diagnosed with thickened heart muscles.I have severe dementia that greatly limits my daily activities.I haven't had a serious GI bleed or bleeding disorder in the last 3 months.I have symptoms from a narrowed heart valve and it affects my daily activities.I can visit the study hospital for all follow-ups and have consent.I can take the required additional medication for the study.I am allergic to certain contrast agents, aspirin, heparin, metals like nickel or titanium, or PET.My heart's mitral valve is significantly narrowed.I have a heart rhythm problem that needed a pacemaker.I have a new heart clot or growth that needs treatment.I have severe heart or blood vessel conditions that make certain procedures unsafe.I have had a stroke or a mini-stroke in the last 6 months.My heart's left ventricle is severely weak, with an ejection fraction under 20%.My kidney function is very low.I had a heart attack within the last 30 days.I am on dialysis or my kidney function is very low.
Research Study Groups:
This trial has the following groups:- Group 1: Commercial Valve - Extended Durability Randomized
- Group 2: ACURATE Valve - Continued Access Study
- Group 3: Commercial Valve - Main Randomized
- Group 4: ACURATE Valve - Extended Durability Randomized
- Group 5: ACURATE Valve - Main Randomized
- Group 6: ACURATE Valve - Single-arm Roll-in
- Group 7: ACURATE Valve - Single-arm Prime XL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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