DurAVR™ THV EU-EFS

Launched by ANTERIS TECHNOLOGIES LTD. · Jul 15, 2024

Keywords

ClinConnect Summary

The DurAVR™ THV EU-EFS clinical trial is looking at a new treatment option for patients with severe aortic stenosis, which is a condition where the heart's aortic valve becomes narrow and can lead to serious health issues. This study aims to assess the safety and effectiveness of the DurAVR™ THV System, a device designed to replace a damaged aortic valve. It will involve patients who have symptoms of this condition and need a valve replacement, and it will be conducted at multiple centers. The trial is currently not recruiting participants.

To be eligible for the study, participants must be at least 18 years old and have severe aortic stenosis or problems with a previously implanted aortic valve. They also need to be suitable for a specific type of valve delivery method called transfemoral delivery, which involves accessing the heart through a blood vessel in the leg. Participants will be expected to understand the study, agree to follow the procedures, and attend all necessary follow-up visits. It’s important to note that certain health conditions may exclude someone from participation, such as having other serious heart issues or recent severe health events. Overall, this trial offers a potential new option for patients needing aortic valve replacement, with the goal of improving their heart health and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
• • 2. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
• • 3. Eligible for transfemoral delivery of the DurAVR™ THV
• • 4. Anatomy appropriate to accommodate safe placement of DurAVR™ THV
• • 5. Understands the study requirements and the treatment procedures and provides written informed consent
• • 6. Subject agrees to complete all required scheduled follow-up visits.
• Exclusion Criteria:
• • 1. Anatomy precluding safe placement of DurAVR™ THV
• • 2. Pre-existing prosthetic mitral or tricuspid valve
• • 3. Unicuspid, bicuspid or non-calcified aortic valve
• • 4. Severe mitral or severe tricuspid regurgitation requiring intervention
• • 5. Moderate to severe mitral stenosis
• • 6. Hypertrophic obstructive cardiomyopathy
• • 7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
• • 8. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
• • 9. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
• • 10. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• • 11. End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min
• • 12. GI bleeding within the past 3 months
• • 13. Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
• • 14. Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions