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Completed

NCT Number: NCT03417011

FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH - Universitätsklinikum, Graz, Austria

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About this study

Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
  • High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team)
  • Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations
  • Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
  • Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.

Exclusion criteria

  • Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
  • Preexisting mechanical heart valve in aortic position
  • Ongoing sepsis, including active endocarditis
  • Anatomically not suitable for the Evolut™ PRO system
  • Estimated life expectancy of less than 1 year
  • Participating in another trial that may influence the outcome of this study
  • Need for emergency surgery for any reason
  • Inability to understand and respond to the quality of life questionnaire

Treatment and study plan

Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)

Device

Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days post procedure

    The all-cause mortality rate at 30 days post procedure meets a prespecified performance goal of 5.5%.

Secondary outcomes

  1. Total AR

    Time frame: 24 hours to 7 days post procedure (prior to discharge)

    The percentage of subjects graded as none or trace total aortic regurgitation at discharge is greater than a prespecified performance goal of 67.1%.

  2. VARC-2 composite safety endpoint

    Time frame: through 5 years from enrollment until end of study

    Event rate of the VARC-2 composite safety endpoint through 5 years from enrollment until end of study, which includes the following components:

    • 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 (BAV, TAVI, or SAVR)

  3. Individual components of the VARC-2 composite safety endpoint

    Time frame: through 5 years from enrollment until end of study

    Event rates of the individual components of the VARC-2 composite safety endpoint through 5 years until end of study

  4. Rate of new permanent pacemaker implant

    Time frame: 30 days post procedure

    Rate of new permanent pacemaker implant at 30 days post procedure

  5. Device success rate

    Time frame: 24 hours to 7 days post procedure (prior to discharge)

    Device success rate at 24 hours to 7 days post procedure (prior to discharge), defined according to the VARC-2 guidelines as:

    • Absence of procedural mortality, AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
    • Intended performance of the prosthetic heart valve, defined as the absence of patient prosthesis mismatch and mean gradient <20 mmHg (or peak velocity <3 m/sec), AND
    • No moderate or severe prosthetic valve regurgitation.

  6. Hemodynamic performance

    Time frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post

    Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the mean prosthetic valve gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

  7. Hemodynamic performance

    Time frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post

    Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the effective orifice area as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

  8. Hemodynamic performance

    Time frame: 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post

    Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the degree of prosthetic valve regurgitation (transvalvular, paravalvular and total) as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

  9. Change in NYHA functional status

    Time frame: From baseline to 30-day, 1-year, 3-year, and 5-year post procedure

    Change in NYHA functional status from baseline to 30-day, 1-year, 3-year, and 5-year post procedure

  10. Change in Quality of Life score

    Time frame: From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure

    Change in Quality of Life score (EQ-5D questionnaire) from baseline to 30-day, and 1-year, 3-year, and 5-year post procedure. The EQ-5D descriptive system comprises five dimensions and each dimension has five levels of severity. The subject is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the subject's self-rated health on a 20 cm vertical, visual analogue scale. The subject marks an X on the scale to indicate how his/her health is TODAY and then writes the number they marked on the scale in the box below.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2024
First posted
Jan 31, 2018
Registry last updated
Sep 9, 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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