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Bioprosthesis

Aortic Valve Replacement for Aortic Stenosis (PERIGON Trial)

N/A
Waitlist Available
Led By Prof. Dr. Robert Johannes Menno Klautz, 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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Change in NYHA Functional Classification Status From Baseline
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 From Years 6 - 12 Post-implant by Freedom From Valve-related Death
+17 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Model 400 aortic valve bioprosthesisExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,059 Total Patients Enrolled
Medtronic Cardiac SurgeryLead Sponsor
7 Previous Clinical Trials
8,310 Total Patients Enrolled
MedtronicIndustry Sponsor
611 Previous Clinical Trials
827,577 Total Patients Enrolled

Media Library

Model 400 Aortic Valve Bioprosthesis (Bioprosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT02088554 — N/A
Aortic Stenosis Research Study Groups: Model 400 aortic valve bioprosthesis
Aortic Stenosis Clinical Trial 2023: Model 400 Aortic Valve Bioprosthesis Highlights & Side Effects. Trial Name: NCT02088554 — N/A
Model 400 Aortic Valve Bioprosthesis (Bioprosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02088554 — N/A
~117 spots leftby Jul 2025
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