Aortic Valve Replacement for Aortic Stenosis

(PERIGON Trial)

Recruiting at 39 trial locations

Overseen By Maggie Haltvick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: Up to 30 days post-implant

1312 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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

I need a new heart valve due to severe narrowing or leakage.

I understand the trial's risks and am willing to consent.

I am old enough to make my own medical decisions where I live.

Exclusion Criteria

I have a heart or lung condition that makes surgery very risky.

My heart's pumping ability is severely reduced.

I had a stroke or heart attack recently and haven’t fully recovered.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Model 400 aortic valve bioprosthesis implant

Up to 30 days post-implant

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness, including evaluation of NYHA classification and effective orifice area

1 year

3-6 months, and 1 year post-implant

Extended Follow-up

Participants are monitored annually for hemodynamic performance and valve-related adverse events

5 years

Annually, at years 2, 3, 4, and 5 post-implant

Long-term Follow-up

Select sites follow participants for extended monitoring of valve performance and safety

12 years

Annually, years 6 through 12 post-implant

Treatment Details

Interventions

• Model 400 Aortic Valve Bioprosthesis

Trial Overview This study tests the safety and effectiveness of the Model 400 aortic valve bioprosthesis in patients needing a new aortic valve due to stenosis or regurgitation, alone or alongside other procedures.

Participant Groups

Group I: Model 400 aortic valve bioprosthesis Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

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

Trials

10

Recruited

9,900+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

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

References

1. England pubmed.ncbi.nlm.nih.gov

Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Reoperative surgery for degenerated aortic bioprostheses: predictors for emergency surgery and reoperative mortality. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Cardiovascular risk factors as predictors of early and late survival after bioprosthetic valve replacement for aortic stenosis. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of Long-term Performance of Bioprosthetic Aortic Valves in Sweden From 2003 to 2018. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized comparison of 3 contemporary bioprosthetic aortic valves: should hemodynamic performance influence device selection? [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

[Hemodynamic studies after the implantation of Hancock-heart valves (author's transl)]. [2007]

7. Germany pubmed.ncbi.nlm.nih.gov

Functional performance of 8 small surgical aortic valve bioprostheses: an in vitro study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Aortic valve replacement with the Cardioprotese Premium bovine pericardium bioprosthesis: four-year clinical results. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Nineteen-Millimeter Bioprosthetic Aortic Valves Are Safe and Effective for Elderly Patients With Aortic Stenosis. [2017]