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

Active, not recruiting

• Conditions: Transcatheter Aortic Valve Implantation

• Registration Number: NCT03613246
• Lead Sponsor: NVT GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-03
• Study Start: 2019-02-20
• Status Verified: 2024-05
• Primary Completion: 2024-12-20
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Study Completion: 2029-01-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 346

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular death	30 days post-index procedure

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	up to five years
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
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, 36 month, 48 month, 60 month
New pacemaker implantation	up to five years
assessment of mean aortic gradient post-implantation	up to five years

Trial Locations

Locations (14)

Schuechtermann-klinik; 🇩🇪 Bad Rothenfelde, Germany

Clinica Mediterranea Neapel; 🇮🇹 Naples, Italy

Morriston Hospital; 🇬🇧 Swansea, United Kingdom

Oulu University Hospital; 🇫🇮 Oulu, Finland

Herz- und Gefäßzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Germany

Kath. Marienkrankenhaus; 🇩🇪 Hamburg, Germany

MH Hannover; 🇩🇪 Hannover, Germany

SLK-Kliniken Heilbronn; 🇩🇪 Heilbronn, Germany

Ospedale San Raffaele; 🇮🇹 Milan, Italy

Heartcentre Catharina Hospital Eindhoven; 🇳🇱 Eindhoven, Netherlands

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain