Avalus Ultra Valve for Aortic Valve Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the Avalus Ultra Valve safe for humans?
What makes the Avalus Ultra Valve treatment unique for aortic valve disease?
The Avalus Ultra Valve is a new stented aortic valve bioprosthesis made from bovine pericardial tissue, designed to improve heart function in patients undergoing surgical aortic valve replacement. It has shown good safety and effectiveness, with a high percentage of patients experiencing improved heart function and no need for reintervention within two years.12367
What data supports the effectiveness of the treatment Avalus Ultra Valve for Aortic Valve Disease?
Who Is on the Research Team?
Juan Crestanello, MD
Principal Investigator
Mayo Clinic
Bo Yang, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for adults with aortic valve disease who can undergo heart procedures like AF ablation or PFO closure. Participants must be able to return for follow-ups and give informed consent. It's not suitable for those unable to commit to the study requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are implanted with the Medtronic Avalus Ultra aortic valve bioprosthesis
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Medtronic Avalus Ultra
Medtronic Avalus Ultra is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiac Surgery
Lead Sponsor