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Evolut™ EXPAND TAVR II Pivotal Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05149755
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : April 25, 2023
Information provided by (Responsible Party):
Medtronic Cardiovascular

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

Condition or disease Intervention/treatment Phase
Aortic Stenosis Symptomatic Moderate Aortic Valve Stenosis Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evolut™ EXPAND TAVR II Pivotal Trial
Actual Study Start Date : April 27, 2022
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : December 2034

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)
Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy
Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).

No Intervention: Clinical site determined guideline-directed management and therapy (GDMT) alone
Clinical site determined guideline-directed management and therapy (GDMT) alone

Primary Outcome Measures :
  1. Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention. [ Time Frame: 30 days ]
    Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.

  2. Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline) [ Time Frame: 1 year ]
  2. Composite of all-cause mortality and heart failure hospitalizations or events. [ Time Frame: 2 years ]
  3. Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations [ Time Frame: 2 years ]
  4. Heart failure hospitalizations or events. [ Time Frame: 2 years ]
  5. All-cause mortality [ Time Frame: 2 years ]
  6. Unplanned cardiovascular hospitalizations [ Time Frame: 2 years ]
  7. Days alive and free of unplanned cardiovascular hospitalizations [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Moderate AS, defined as follows by transthoracic echo (TTE) at rest:

    • Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, and
    • Mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg, and
    • AVA >1.0 cm2 and < 1.5 cm2
  • NYHA class ≥ II and symptoms of AS, including but not limited to:

    • Dyspnea at rest or on exertion
    • Fatigue
    • Angina
    • Syncope in the absence of another identifiable cause
  • LVEF > 20% by 2-D echo
  • Any of the following

    • HF event or hospitalization for heart failure within 1 calendar year prior to qualifying echo
    • NT proBNP ≥ 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior to or within 2 weeks after qualifying echo,
    • Global longitudinal strain ≤15% (absolute value) at qualifying echo, or
    • E/e' (average of medial and lateral velocities) ≥ 14.0 at qualifying echo

Key Exclusion Criteria:

  • Age < 65 years
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05149755

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Contact: Hang Nguyen +1765262832
Contact: Hang Nguyen

Show Show 55 study locations
Sponsors and Collaborators
Medtronic Cardiovascular
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Principal Investigator: Paul Sorajja, MD Allina Health System
Principal Investigator: Josep Rodes-Cabau, MD Fondation IUCPQ
Principal Investigator: Stephan Windecker, Prof. Inselspital, Universitätsspital Bern
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Responsible Party: Medtronic Cardiovascular Identifier: NCT05149755    
Other Study ID Numbers: D00411092
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Medtronic Cardiovascular:
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction