Aortic Valve Replacement for Aortic Stenosis
(PERIGON Trial)
Trial Summary
What is the purpose of this trial?
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
Do I need to stop my current medications for the trial?
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.
What data supports the effectiveness of the treatment Model 400 Aortic Valve Bioprosthesis for aortic stenosis?
Research shows that bioprosthetic aortic valves, like the Model 400, are effective in improving survival rates and reducing complications such as stroke and atrial fibrillation (irregular heartbeat) in patients with severe aortic stenosis. These valves are designed to mimic natural heart valves and have been shown to perform well over time, with studies indicating good long-term outcomes.12345
How does the Model 400 Aortic Valve Bioprosthesis treatment for aortic stenosis differ from other treatments?
The Model 400 Aortic Valve Bioprosthesis is a type of bioprosthetic valve used for aortic valve replacement, which is designed to mimic the natural valve and reduce the risk of blood clots compared to mechanical valves. Unlike mechanical valves, bioprosthetic valves like this one do not typically require lifelong blood-thinning medication, but their long-term durability is still being evaluated.16789
Research Team
Joseph Sabik, MD
Principal Investigator
University Hospital Cleveland Medical Center (Not a recruiting site)
Prof. Dr. Robert Johannes Menno Klautz, MD
Principal Investigator
Leiden University Medical Center
Eligibility Criteria
The PERIGON trial is for adults with moderate or severe aortic valve problems who can consent and return for follow-ups. It's not for those previously treated with Model 400, with certain heart conditions, infections, in other trials, pregnant, or with life-threatening non-cardiac diseases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Model 400 aortic valve bioprosthesis implant
Initial Follow-up
Participants are monitored for safety and effectiveness, including evaluation of NYHA classification and effective orifice area
Extended Follow-up
Participants are monitored annually for hemodynamic performance and valve-related adverse events
Long-term Follow-up
Select sites follow participants for extended monitoring of valve performance and safety
Treatment Details
Interventions
- Model 400 Aortic Valve Bioprosthesis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiovascular
Lead Sponsor
Geoff Martha
Medtronic Cardiovascular
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Kendra J. Grubb
Medtronic Cardiovascular
Chief Medical Officer
MD from Emory University
Medtronic Cardiac Surgery
Lead Sponsor
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc