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Evaluating TAVR for patients with moderate aortic valve stenosis

Evolut™ EXPAND TAVR II Pivotal Trial

Not applicable Interventional Medtronic Cardiovascular · NCT05149755

This study is testing if a new heart valve replacement method can help people with moderate aortic valve stenosis feel better compared to just standard care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment650 (estimated)
Ages65 Years and up
SexAll
SponsorMedtronic Cardiovascular Industry-sponsored
Locations99 sites (Birmingham, Alabama and 98 other locations)
Trial IDNCT05149755 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to gather safety and effectiveness data to support the use of the Medtronic TAVR System in patients with moderate aortic valve stenosis. It is a multi-center, international, prospective, randomized study where participants will be assigned to receive either the Evolut PRO+ or Evolut FX TAVR System along with guideline-directed management and therapy, or guideline-directed management alone. The study will assess various clinical outcomes to determine the benefits of TAVR in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with moderate aortic valve stenosis who exhibit specific symptoms or risk factors.

Not a fit: Patients with severe aortic stenosis or those who do not meet the inclusion criteria for moderate aortic stenosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with moderate aortic valve stenosis, potentially improving their quality of life and clinical outcomes.

How similar studies have performed: Other studies have shown success with TAVR approaches in severe aortic stenosis, but this specific application for moderate stenosis is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:

* AVA \>1.0 cm² and \<1.5cm²; or
* AVA ≤ 1.0 cm² with AVAI \> 0.6cm²/m² if BMI \< 30 kg/m²: or
* AVA ≤ 1.0 cm² with AVAI \> 0.5cm²/m² if BMI ≥ 30 kg/m²:

and

* Max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or
* Mean aortic gradient ≥ 20mmHg and \< 40.0 mmHg

Any of the following at-risk features:

* 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)
* Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
* NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
* 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), or
  * E/e' ≥ 14.0 (average of medial and lateral velocities), or
  * Diastolic dysfunction ≥ Grade II, or
  * LVEF \< 60%
  * Stroke Volume Index \< 35 ml/m²
* Anatomically suitable for transfemoral TAVR 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
* Contraindication for placement of a bioprosthetic valve
* Documented history of cardiac amyloidosis

Where this trial is running

Birmingham, Alabama and 98 other locations

+49 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate Aortic Valve StenosisaorticstenosismoderatevalveTAVR
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.