Aortic Valve Replacement for Aortic Stenosis

(PERIGON Trial)

Not currently recruiting at 43 trial locations

Overseen By Maggie Haltvick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Disqualifiers: Prosthetic valve, Active infection, Renal failure, Pregnancy, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new heart valve, the Model 400 aortic valve bioprosthesis. It is designed for individuals with aortic stenosis (a narrowed heart valve) or regurgitation (a leaky valve) who require aortic valve replacement. Participants should be stable in their location and willing to attend follow-up visits. Individuals with these heart issues considering surgery might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

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 prior data suggests that the Model 400 aortic valve bioprosthesis is safe for aortic stenosis?

Research has shown that the Model 400 Aortic Valve Bioprosthesis is generally well-tolerated. Earlier studies reported no early deaths, and survival rates remained strong over 11 years. However, some risks include bleeding, valve clotting, and infections. Overall, the device has a good safety record, indicating it is safe for most people. Prospective trial participants should consult their doctor to determine if participation is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Model 400 Aortic Valve Bioprosthesis is unique because it offers a new approach to treating aortic stenosis, a condition where the heart's aortic valve narrows, limiting blood flow. Unlike traditional mechanical valves, which require lifelong blood-thinning medication, this bioprosthesis is designed to work more naturally with the body, potentially reducing the need for such medication. Researchers are excited about this treatment because it may offer a more durable and biocompatible solution, reducing complications and improving quality of life for patients compared to standard metal or tissue valves.

What evidence suggests that the Model 400 aortic valve bioprosthesis is effective for aortic stenosis?

Research shows that the Model 400 aortic valve replacement, which participants in this trial will receive, performs well over the long term. Studies have found that it maintains good heart function and blood flow for up to 11 years after surgery. This indicates the valve effectively improves heart health for an extended period. It replaces damaged aortic valves, crucial for patients with conditions like aortic stenosis, where the heart's aortic valve narrows. Overall, evidence supports that this valve successfully restores heart valve function and enhances quality of life for those needing aortic valve replacement. ^{1 2 3 4 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16039192/

Long-term results after aortic valve replacement with the ... The Bravo Cardiovascular Model 400 stentless xenograft has provided good clinical and hemodynamic results up until 11 years of follow-up.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02088554

Study Details | NCT02088554 | PERIGON Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170006B.pdf

summary of safety and effectiveness data (ssed) The Avalus™ bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. III. CONTRAINDICATIONS.

4. withpower.com withpower.com/trial/phase-aortic-valve-stenosis-4-2014-f94e0

Aortic Valve Replacement for Aortic Stenosis · Info ... 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003497505003917

Long-Term Results After Aortic Valve Replacement With ... The Bravo Cardiovascular Model 400 stentless xenograft has provided good clinical and hemodynamic results up until 11 years of follow-up.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28475690/

Safety, effectiveness and haemodynamic performance of a ... This analysis demonstrated a good safety profile and clinical effectiveness of the Avalus valve except for bleeding rates.