NL-OMON54842已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
- •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
- •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.
排除标准
- •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.
研究者
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