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

Key facts

Who runs it
NVT GmbH
Where
Finland, Germany, Italy, Netherlands, Spain, and United Kingdom14 sites in 6 countriesChoose a country to see its sites
Trial code
Status
Active, not recruiting
People taking part
346 people enrolled
Started
20 Feb 2019
Expected to end
26 Jan 2029
Type of study
Observational, 2 groups
Record updated
17 November 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Currently participating in another investigational drug or device study; Patients with native aortic valve disease:
  • Distance between aortic valve basal plane and the orifice of the lowest coronary artery < 8 mm; Patients with degenerated surgical bioprosthetic aortic valves:
  • 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
  • Evidence of active endocarditis or other acute infections
  • Renal failure requiring continuous renal replacement therapy
  • Life expectancy ≤ 12 months due to other medical illness
  • Combined aortic valve disease with predominant aortic regurgitation > 3
  • Severe ventricular dysfunction with LVEF <20%
  • 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
  • General:
  • Echocardiographic evidence of intracardiac thrombus or vegetation
  • Unicuspid or bicuspid aortic valve
  • Non-calcified aortic stenosis
  • 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

This trial has no sites in United States.

It has sites in 6 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Cohort 1: Patients who undergo TAVI for symptomatic severe stenosed aortic heart valves
  • Cohort 2:

    patients undergoing a VIV procedure in failing surgical bioprostheses.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
17 November 2025