NL-OMON54842
Completed
Not Applicable
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. - PERIGON Pivotal Trial LTF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Replacement
- Sponsor
- Medtronic B.V.
- Enrollment
- 120
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •iii. PFO closure
- •iv. Ascending aortic aneurysm or dissection repair not requiring circulatory
- •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
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)
Outcomes
Primary Outcomes
Not specified
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