Clinical trial NCT03613246: NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transcatheter Aortic Valve Implantation
Keywords: TAVI
Aortic valve stenosis
ALLEGRA
Lead sponsor: NVT GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic patients with elevated surgical risk and candidate for TAVI with severe calcified and stenotic aortic valves or failing surgical bioprosthetic aortic valves.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular death
timeFrame: 30 days post-index procedure
Secondary outcomes:
measure: All-cause mortality
timeFrame: up to five years
measure: Technical success of implantation
timeFrame: day of procedure
measure: Assesment of NYHA classification
timeFrame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
measure: Safety profile according to VARC II
timeFrame: 30 days
measure: In-hospital mortality
timeFrame: date of procedure till date of estimated discharge, assessed up to two weeks
measure: Quality of life (EQ5D 5L)
timeFrame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
measure: New pacemaker implantation
timeFrame: up to five years
measure: assessment of mean aortic gradient post-implantation
timeFrame: up to five years
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Bad Bevensen
country: Germany
facility: Herz- und Gefäßzentrum Bad Bevensen
city: Bad Rothenfelde
country: Germany
facility: Schuechtermann-klinik
city: Hamburg
country: Germany
facility: Kath. Marienkrankenhaus
city: Hannover
country: Germany
facility: MH Hannover
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Naples
country: Italy
facility: Clinica Mediterranea Neapel
city: Eindhoven
country: Netherlands
facility: Heartcentre Catharina Hospital Eindhoven
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Herz-und Gefäßzentrum Bad Bevensen, Germany
name: Ulrich Schäfer, MD
role: PRINCIPAL_INVESTIGATOR
References: