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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a minimum of 15 subjects per valve size will be following through one year
Awards & highlights
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 belowSelect...
I need a new heart valve due to severe narrowing or leakage.
Select...
I can travel to the clinic for follow-ups.
PERIGON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ a minimum of 15 subjects per valve size will be following through one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a minimum of 15 subjects per valve size will be following through one year
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.
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?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,019 Total Patients Enrolled
Medtronic Cardiac SurgeryLead Sponsor
7 Previous Clinical Trials
8,310 Total Patients Enrolled
MedtronicIndustry Sponsor
605 Previous Clinical Trials
826,882 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I need emergency surgery.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.I have severe heart relaxation issues.You have more than a mild leaking of the mitral or tricuspid heart valves as shown by an ultrasound test.I have a condition that causes abnormal bleeding.I can travel to the clinic for follow-ups.I have an active heart infection or a serious systemic infection.You have had a specific type of aortic valve implanted and then removed.I have a heart valve device or need a valve repair/replacement.I have a serious illness other than heart disease, expected to live less than 2 years.You have a history of using drugs or alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: Model 400 aortic valve bioprosthesis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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