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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a minimum of 15 subjects per valve size will be following through one year
Awards & highlights
No Placebo-Only Group

PERIGON Trial 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.

PERIGON Trial 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.
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I am old enough to make my own medical decisions where I live.
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I understand the trial's risks and am willing to consent.

PERIGON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a minimum of 15 subjects per valve size will be following through one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and a minimum of 15 subjects per valve size will be following through one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the safety of the Model 400 valve with regard to valve-related adverse events and death.
Secondary outcome measures
Confirm the effectiveness of the Model 400 valve, with regard to NYHA Functional Classification and hemodynamic performance.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

PERIGON Trial Design

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

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
604 Previous Clinical Trials
827,646 Total Patients Enrolled
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,005 Total Patients Enrolled
Medtronic Cardiac SurgeryLead Sponsor
7 Previous Clinical Trials
8,296 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on enrolment for this clinical experiment?

"To successfully complete this medical trial, 1290 eligible participants must be enrolled. The University of Michigan Cardiovascular Center in Ann Arbor and the Mount Sinai Medical Centre in New york City are just two of many sites where individuals can participate."

Answered by AI

Are there any Canadian locations where this research is being conducted?

"A total of 5 medical centres are currently enrolling patients, including University of Michigan Cardiovascular Center in Ann Arbor, The Mount Sinai Medical Center in New york and ProMedica Toledo Hospital in Toledo. Additionally, there is a further selection of clinical trial sites available."

Answered by AI

Are there still open slots available in this trial for prospective participants?

"According to the clinicaltrials.gov archive, this trial is presently open for recruitment and was initially posted on May 12th 2014 with its most recent edit being made November 7th 2022."

Answered by AI
~122 spots leftby Feb 2025