RECRUITING

Evolut™ EXPAND TAVR II Pivotal Trial

Description

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

Conditions

Moderate Aortic Valve Stenosis
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Related Conditions:

Moderate Aortic Valve Stenosis

Study Overview

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Study Details

Study overview

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

Evolut™ EXPAND TAVR II Pivotal Trial

Evolut™ EXPAND TAVR II Pivotal Trial

Condition
Moderate Aortic Valve Stenosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States, 35233

Phoenix

Abrazo Arizone Heart Hospital, Phoenix, Arizona, United States, 85016

Scottsdale

HonorHealth Scottsdale Shea Medical Center, Scottsdale, Arizona, United States, 85260

Thousand Oaks

Los Robles Hospital & Medical Center, Thousand Oaks, California, United States, 91360

Aurora

University of Colorado Hospital, Aurora, Colorado, United States, 80045

Bridgeport

Saint Vincents Medical Center, Bridgeport, Connecticut, United States, 06606-4201

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06106

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Clearwater

Morton Plant Hospital, Clearwater, Florida, United States, 33756

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiovascular,

Paul Sorajja, MD, PRINCIPAL_INVESTIGATOR, Allina Health System

Josep Rodes-Cabau, MD, PRINCIPAL_INVESTIGATOR, Fondation IUCPQ

Stephan Windecker, Prof., PRINCIPAL_INVESTIGATOR, Inselspital, Universitätsspital Bern

Study Record Dates

2034-12