Transcatheter Aortic Valve Implantation
Conditions
Keywords
TAVI, Aortic valve stenosis, ALLEGRA
Brief summary
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.
Interventions
None listed
Sponsors
NVT GmbH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve 2. Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use) 3. High risk for surgery as assessed by the heart team 4. Has signed the Patient Informed Consent Form \>= 18 years
Exclusion criteria
General: 1. Echocardiographic evidence of intracardiac thrombus or vegetation 2. 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 3. 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 4. Severe ventricular dysfunction with LVEF \<20% 5. Evidence of active endocarditis or other acute infections 6. Renal failure requiring continuous renal replacement therapy 7. 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 8. Life expectancy ≤ 12 months due to other medical illness 9. Currently participating in another investigational drug or device study Patients with native aortic valve disease: 1. Unicuspid or bicuspid aortic valve 2. Non-calcified aortic stenosis 3. Combined aortic valve disease with predominant aortic regurgitation \> 3 4. Distance between aortic valve basal plane and the orifice of the lowest coronary artery \< 8 mm Patients with degenerated surgical bioprosthetic aortic valves: 1. Low position of the coronary ostia, especially in combination with shallow sinuses 2. Internal diameter of the bioprosthesis is ≤16 mm or \>28 mm 3. Partially detached leaflets that in the aortic position may obstruct a coronary ostium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular death | 30 days post-index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of implantation | day of procedure | 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 |
| Assesment of NYHA classification | 30 days, 12 month, 24 month, 36 month, 48 month, 60 month | — |
| Safety profile according to VARC II | 30 days | 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 |
| All-cause mortality | up to five years | — |
| Quality of life (EQ5D 5L) | 30 days, 12 month, 24 month, 36 month, 48 month, 60 month | — |
| New pacemaker implantation | up to five years | — |
| assessment of mean aortic gradient post-implantation | up to five years | — |
| In-hospital mortality | date of procedure till date of estimated discharge, assessed up to two weeks | — |
Countries
Finland, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed