ACURATE TAVR System for Aortic Stenosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new heart valve, the ACURATE neo2 Transfemoral TAVR System, for treating severe aortic stenosis. This condition narrows the heart's aortic valve, causing symptoms like chest pain and shortness of breath. The trial compares this new valve with existing ones to assess its safety and effectiveness. Individuals diagnosed with severe aortic stenosis, experiencing symptoms that impact daily life, such as difficulty breathing during regular activities, may be suitable for this study. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future treatment options.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be able to take the study's required medications, and you cannot have allergies to them.
What prior data suggests that the ACURATE TAVR System is safe for transcatheter aortic valve replacement?
Research has shown that the ACURATE neo2 Transfemoral TAVR System is generally safe. In one study, 246 patients used this system, and only 5.1% passed away from any cause after one year, indicating that the treatment is usually well-tolerated. Another study found that the system performed well and remained safe for up to one year in regular medical settings.
For the ACURATE Prime Transfemoral TAVR System XL, early results from a human study showed no safety issues. No deaths or strokes were reported within 30 days after treatment. These findings suggest that both systems are safe options for patients with severe aortic stenosis considering transcatheter aortic valve replacement (TAVR).12345Why are researchers excited about this trial's treatments?
Researchers are excited about the ACURATE neo2™ Transfemoral TAVR System because it offers advancements in treating aortic stenosis, a condition where the heart's aortic valve narrows. Unlike standard treatments like the balloon-expandable SAPIEN 3 or self-expanding CoreValve systems, the ACURATE neo2™ aims to improve procedural efficiency and outcomes through its innovative design. Key features include its self-expanding technology that may offer enhanced valve positioning and sealing, potentially reducing complications such as leaks. Additionally, the transfemoral approach simplifies the procedure by accessing the heart through the femoral artery in the leg, which can be less invasive and allow for quicker recovery times. These innovations could make a significant difference for patients, particularly those who are at low risk.
What evidence suggests that this trial's treatments could be effective for aortic stenosis?
Research has shown that the ACURATE neo2 Transfemoral TAVR System, one of the treatments in this trial, effectively treats severe aortic stenosis, a condition where the heart valve doesn't open properly. Thirty days after the procedure, 79.2% of patients experienced little to no leakage around the new valve, with no cases of severe leakage. After one year, patients showed similar survival rates and health outcomes compared to those with other heart valves.
For the ACURATE Prime Transfemoral TAVR System XL, another treatment option in this trial, early studies have demonstrated its safety. Initial testing reported no deaths or strokes within 30 days, indicating the valve's safety and potential effectiveness. Both systems aim to help people with aortic stenosis by replacing the faulty heart valve without requiring open-heart surgery.13567Who Is on the Research Team?
Raj Makkar
Principal Investigator
Cedars-Sinai Heart Institute
Michael J. Reardon, MD
Principal Investigator
Methodist DeBakey Heart & Vascular Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the ACURATE Transfemoral Aortic Valve System or a comparator device for transcatheter aortic valve replacement
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Durability Study
An additional randomized study for subjects at low surgical risk to assess long-term durability of the ACURATE valve
What Are the Treatments Tested in This Trial?
Interventions
- ACURATE neo2™ Transfemoral TAVR System
- ACURATE Prime™ Transfemoral TAVR System XL
- Edwards SAPIEN 3 TAVR System
- Medtronic CoreValve TAVR System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology