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

Transcatheter Aortic Valve Implantation Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03613246
• Other study ID #: NVT04FOL
• Status: Recruiting
• Start date: February 20, 2019
• Est. completion date: February 2025

Study information

• Verified date: April 2022
• Source: NVT GmbH
• Contact: Martin Faiss, PhD
• Phone: +49 7471 98979
• Email: m.faiss[@]nvt-med.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Implantation

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu
Germany	Herz- und Gefäßzentrum Bad Bevensen	Bad Bevensen
Germany	Kath. Marienkrankenhaus	Hamburg
Germany	MH Hannover	Hannover
Germany	SLK-Kliniken Heilbronn	Heilbronn
Italy	Ospedale San Raffaele	Milan
Netherlands	Heartcentre Catharina Hospital Eindhoven	Eindhoven
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Alvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
NVT GmbH

Countries where clinical trial is conducted

Finland,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular death		30 days post-index procedure
Secondary	All-cause mortality		up to two years
Secondary	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
Secondary	Assesment of NYHA classification		30 days, 12 month, 24 month
Secondary	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
Secondary	In-hospital mortality		date of procedure till date of estimated discharge, assessed up to two weeks
Secondary	Quality of life (EQ5D 5L)		30 days, 12 month, 24 month
Secondary	New pacemaker implantation		up to two years
Secondary	assessment of mean aortic gradient post-implantation		up to two years