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Evolut™ EXPAND TAVR II Pivotal Trial

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ClinicalTrials.gov Identifier: NCT05149755
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date  ICMJE November 24, 2021
First Posted Date  ICMJE December 8, 2021
Last Update Posted Date May 1, 2024
Actual Study Start Date  ICMJE April 27, 2022
Estimated Primary Completion Date February 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2023)
  • 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.
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2021)
  • Composite 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
  • Composite of all-cause mortality, heart failure event, or aortic valve replacement or reintervention [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2022)
  • Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline) [ Time Frame: 1 year ]
  • Composite of all-cause mortality and heart failure hospitalizations or events. [ Time Frame: 2 years ]
  • Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations [ Time Frame: 2 years ]
  • Heart failure hospitalizations or events. [ Time Frame: 2 years ]
  • All-cause mortality [ Time Frame: 2 years ]
  • Unplanned cardiovascular hospitalizations [ Time Frame: 2 years ]
  • Days alive and free of unplanned cardiovascular hospitalizations [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2021)
  • Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline) [ Time Frame: 1 year ]
  • Composite of all-cause mortality and heart failure events (inclusive of hospitalizations) [ Time Frame: 2 years ]
  • Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations (inclusive of all aortic valve replacement (AVR)) [ Time Frame: 2 years ]
  • Heart failure events (inclusive of hospitalizations) [ Time Frame: 2 years ]
  • All-cause mortality [ Time Frame: 2 years ]
  • Unplanned cardiovascular hospitalizations (exclusive of AVR) [ Time Frame: 2 years ]
  • Days alive and free of unplanned cardiovascular hospitalizations (inclusive of all AVR) [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evolut™ EXPAND TAVR II Pivotal Trial
Official Title  ICMJE Evolut™ EXPAND TAVR II Pivotal Trial
Brief Summary Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Moderate Aortic Valve Stenosis
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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
    Intervention: Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2021)		 650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2034
Estimated Primary Completion Date February 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hang Nguyen +1765262832 hang.t.nguyen@medtronic.com
Contact: Hang Nguyen rs.expandii@medtronic.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   Netherlands,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05149755
Other Study ID Numbers  ICMJE D00411092
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Medtronic Cardiovascular
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Cardiovascular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Sorajja, MD Allina Health System
Principal Investigator: Josep Rodes-Cabau, MD Fondation IUCPQ
Principal Investigator: Stephan Windecker, Prof. Inselspital, Universitätsspital Bern
PRS Account Medtronic Cardiovascular
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP