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NCT Number: NCT03613246

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Transcatheter Aortic Valve Implantation Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oulu University Hospital, Oulu, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

General:

  • 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
  • Currently participating in another investigational drug or device study

Patients with native aortic valve disease:

  • Unicuspid or bicuspid aortic valve
  • Non-calcified aortic stenosis
  • Combined aortic valve disease with predominant aortic regurgitation > 3
  • Distance between aortic valve basal plane and the orifice of the lowest coronary artery < 8 mm

Patients with degenerated surgical bioprosthetic aortic valves:

  • 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

Treatment and study plan

Primary outcomes

  1. Cardiovascular death

    Time frame: 30 days post-index procedure

Secondary outcomes

  1. All-cause mortality

    Time frame: up to five years

  2. Technical success of implantation

    Time frame: 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

  3. Assesment of NYHA classification

    Time frame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month

  4. Safety profile according to VARC II

    Time frame: 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

  5. In-hospital mortality

    Time frame: date of procedure till date of estimated discharge, assessed up to two weeks

  6. Quality of life (EQ5D 5L)

    Time frame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month

  7. New pacemaker implantation

    Time frame: up to five years

  8. assessment of mean aortic gradient post-implantation

    Time frame: up to five years

Sponsors and collaborators

Lead sponsor

NVT GmbH

Industry

Registry information

Official study 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

Acronym: FOLLOW

Important dates

Study start
2019
Primary completion
2024
Study completion
2029
First posted
Aug 3, 2018
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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