Purpose

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

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Ron Waksman, MD

More Details

Status
Recruiting
Sponsor
Medtronic Cardiovascular

Study Contact

Hang Nguyen
+1765262832
hang.t.nguyen@medtronic.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.