Active — Not RecruitingNot Applicable

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

Finland, Germany346 participantsStarted 2019-02-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Echocardiographic evidence of intracardiac thrombus or vegetation
✕. 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
✕. Severe ventricular dysfunction with LVEF \<20%
✕. Evidence of active endocarditis or other acute infections
✕. Renal failure requiring continuous renal replacement therapy
✕. 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
✕. Life expectancy ≤ 12 months due to other medical illness

What they're measuring

Cardiovascular death

Timeframe: 30 days post-index procedure

Trial details

NCT IDNCT03613246

SponsorNVT GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-20

View on ClinicalTrials.gov More Transcatheter Aortic Valve Implantation trials