NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population

Study Overview
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Brief Summary
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The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.

Official Title
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Clinical Outcomes of the NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population With Elevated Surgical Risk

Conditions
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Transcatheter Aortic Valve Implantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use) High risk for surgery as assessed by the heart team Has signed the Patient Informed Consent Form >= 18 years Exclusion Criteria: General: Echocardiographic evidence of intracardiac thrombus or vegetation Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible Severe ventricular dysfunction with LVEF <20% Evidence of active endocarditis or other acute infections Renal failure requiring continuous renal replacement therapy Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue Life expectancy ≤ 12 months due to other medical illness Currently participating in another investigational drug or device study Patients with native aortic valve disease: Unicuspid or bicuspid aortic valve Non-calcified aortic stenosis Combined aortic valve disease with predominant aortic regurgitation > 3 Distance between aortic valve basal plane and the orifice of the lowest coronary artery < 8 mm Patients with degenerated surgical bioprosthetic aortic valves: Low position of the coronary ostia, especially in combination with shallow sinuses Internal diameter of the bioprosthesis is ≤16 mm or >28 mm Partially detached leaflets that in the aortic position may obstruct a coronary ostium

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | 30 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | up to two years | 
| Technical success of implantation | Technical success of implantation, as defined by: absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND no prosthesis - patient mismatch AND mean aortic valve gradient <20 mmHg, AND no moderate or severe prosthetic valve regurgitation | day of procedure | 
| Assesment of NYHA classification |  | 30 days, 12 month, 24 month | 
| Safety profile according to VARC II | Early Safety All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure Time-related valve safety Structural valve deterioration as defined by Requiring repeat procedure (transcatheter or surgical heart valve replacement) Valve-related dysfunction defined by mean aortic valve gradient ≥20 mmHg and no moderate or severe prosthetic valve regurgitation Prosthetic valve endocarditis Prosthetic valve thrombosis Thrombo-embolic events (e.g. stroke) VARC bleeding, unless clearly unrelated to valve therapy | 30 days | 
| In-hospital mortality |  | date of procedure till date of estimated discharge, assessed up to two weeks | 
| Quality of life (EQ5D 5L) |  | 30 days, 12 month, 24 month | 
| New pacemaker implantation |  | up to two years | 
| assessment of mean aortic gradient post-implantation |  | up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Aortic valve stenosis, ALLEGRA