Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON) Long-term Follow-Up. 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.

Completed

Conditions: Aortic Valve Replacement
new heart valve
10046973

Registration Number: NL-OMON54842

Lead Sponsor: Medtronic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. 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, which are
limited to any of the following:
i. LAA ligation
ii. CABG
iii. PFO closure
iv. Ascending aortic aneurysm or dissection repair not requiring circulatory
arrest
v. Resection of a sub-aortic membrane not requiring myectomy
2. Patient is geographically stable and willing to return to the implanting
site for all follow-up visits
3. Patient is of legal age to provide informed consent in the country where
they enroll in the trial
4. Patient has been adequately informed of risks and requirements of the trial
and is willing and able to provide informed consent for participation in the
clinical trial

LTFU:
1. Subject is a participant in the PERIGON Pivotal Trial and is implanted with
the Avalus valve;
2. Patient is of legal age to provide informed consent in the country where
they enroll in the trial;
3. Patient has been adequately informed of risks and requirements of the trial
and is willing and able to provide informed consent for participation in the
clinical trial;
4. Patients must be geographically stable and willing to return to the
implanting site for all follow-up visits.

Exclusion Criteria

1. Patient has a pre-existing prosthetic valve or annuloplasty device in
another position or requires replacement or repair of the mitral, pulmonary or
tricuspid valve 2. Patient has had previous implant and then explant of the
Model 400 aortic valve bioprosthesis 3. Patient presents with active
endocarditis, active myocarditis or other systemic infection 4. 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)
5. Patient has a non-cardiac major or progressive disease, with a life
expectancy of less than 2 years. These conditions include, but are not limited
to: • Child-Pugh Class C liver disease • Terminal cancer • End-stage lung
disease 6. Patient has renal failure, defined as dialysis therapy or GFR<30
mL/min/1.73 m2 7. Patient has hyperparathyroidism 8. Patient is participating
in another investigational device or drug trial or observational competitive
study 9. Patient is pregnant, lactating or planning to become pregnant during
the trial period 10. Patient has a documented history of substance (drug or
alcohol) abuse 11. Patient has greater than mild mitral valve regurgitation or
greater than mild tricuspid valve regurgitation as assessed by echocardiography
12. Patient has systolic EF<20% as assessed by echocardiography 13. Patient
has Grade IV Diastolic Dysfunction 14. Patient has documented bleeding
diatheses 15. Patient has had an acute preoperative neurological deficit or
myocardial infarction and has not returned to baseline or stabilized >=30 days
prior to enrollment 16. Patient requires emergency surgery LTFU: 1. Subjects
who have had an explant of the Avalus valve prior to the long-term follow up
study period; 2. Subjects who have had a valve in valve prior to the long-term
follow up study period; 3. Subject unable or unwilling to return for study
follow-up visits.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Safety:<br /><br>a. Thromboembolism<br /><br>b. Valve Thrombosis<br /><br>c. Hemorrhage<br /><br>d. Paravalvular leak<br /><br>e. Endocarditis<br /><br>f. Hemolysis<br /><br>g. Structural valve deterioration<br /><br>h. Non-structural dysfunction<br /><br>i. Reintervention<br /><br>j. Explant<br /><br>k. Death<br /><br>2. Effectiveness:<br /><br>a. Hemodynamic Performance Metrics<br /><br>b. New York Heart Association Functional Classification</p><br>

Secondary Outcome Measures