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Bioprosthesis

Aortic Valve Replacement for Aortic Stenosis (PERIGON Trial)

N/A

Waitlist Available

Led By Joseph Sabik, MD

Research Sponsored by Medtronic Cardiovascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures

Patient is geographically stable and willing to return to the implanting site for all follow-up visits

Must not have

Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including ascending aortic aneurysm or dissection repair requiring circulatory arrest, acute Type A aortic dissection, ventricular aneurysm, porcelain aorta, hostile mediastinum, hypertrophic obstructive cardiomyopathy (HOCM), documented pulmonary hypertension (systolic >60mmHg)

Patient has systolic EF<20% as assessed by echocardiography

Timeline

Screening 3 weeks

Treatment Varies

Follow Up annually, at years 2, 3, 4, and 5 post-implant

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of a new aortic valve.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified here but generally may include risks associated with heart valve replacement such as bleeding, blood clots, infection, stroke and potential failure of the new bioprosthesis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can travel to the clinic for follow-ups.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My heart's pumping ability is severely reduced.

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I need emergency surgery.

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I have severe heart relaxation issues.

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I have a condition that causes abnormal bleeding.

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I have an active heart infection or a serious systemic infection.

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I have a heart valve device or need a valve repair/replacement.

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I have a serious illness other than heart disease, expected to live less than 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ annually, at years 2, 3, 4, and 5 post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~annually, at years 2, 3, 4, and 5 post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and annually, at years 2, 3, 4, and 5 post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure

+6 more

Secondary study objectives

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure

+6 more

Other study objectives

Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From All-cause Mortality

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting )

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 12 Years Post-implant

+15 more