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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.
 
ClinicalTrials.gov Identifier: NCT05149755
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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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.
Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT05149755


Contacts
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Contact: Hang Nguyen +1765262832 hang.t.nguyen@medtronic.com
Contact: Hang Nguyen rs.expandii@medtronic.com

Locations
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Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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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
More Information
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT05149755    
Other Study ID Numbers: D00411092
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
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:
aortic
stenosis
symptomatic
 moderate
valve
TAVR
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