Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(352) 733-0111

EXPAND II

  • Status
    Accepting Candidates
  • Age
    65 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Objective

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS.

Description

Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.

Details

Full study title Evolut EXPAND TAVR II Pivotal Trial
Protocol number OCR43345
ClinicalTrials.gov ID NCT05149755
Phase N/A

Eligibility

Key Inclusion Criteria:

• Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the

Ecl:

  • AVA >1.0 cm² and < 1.5 cm² and

  • Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, OR mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg, • Symptoms of AS, defined as

  • NYHA ≥ Class II, or

  • Reduced functional capacity, defined as

  • 6MWT < 300 meters, or

  • < 85% of age-sex predicted METs on exercise tolerance testing (ETT) • Any of the following

  • HF event or hospitalization for heart failure within 1 calendar year prior to consent

  • NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml),

  • Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or

  • Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or

  • Any of the following by the qualifying TTE as assessed by the ECL:

  • Global longitudinal strain ≤16% (absolute value)

  • E/e' ≥ 14.0 (average of medial and lateral velocities), or

  • Diastolic dysfunction ≥ Grade II

  • LVEF < 60%

  • Stroke Volume Index < 35 ml/m²

  • Anatomically suitable for transfemoral RAVR using the Medtronic Evolut PRO+ or Evolut FX system

  • The subject and the treating physician agree the subject will return for all required follow-up visits

Key Exclusion Criteria:

  • Age < 65 years

  • LVEF ≤ 20% by 2-D echo

  • Class I indication for cardiac surgery

  • Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm

  • Not anatomically suitable for transfemoral TAVR with the trial device

  • In need of and suitable for coronary revascularization per Heart Valve Team

  • Documented history of cardiac amyloidosis

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.