Last updated on October 2016

Low Risk TAVR-The purpose of this research study is to determine if replacing the aortic valve without open-heart surgery is as safe as or safer than open-heart surgery in patients who are considered at low risk for complications from surgery.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart Valve Disease
  • Age: 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Severe, degenerative AS, defined as:
    1. mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND
    2. calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2
  2. Symptomatic AS, defined as a history of at least one of the following:
    1. dyspnea that qualifies at New York Heart Association (NYHA) class II or greater
    2. angina pectoris
    3. cardiac syncope
  3. The Heart Team, including at least one cardiothoracic surgeon and one interventional cardiologist, deem the patient to be reasonable for transfemoral TAVR with a commercially available bioprosthetic valve
  4. The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered.
  5. The Heart Team agrees that transfemoral TAVR is anatomically feasible, based upon multislice CT measurements
  6. Procedure status is elective
  7. Expected survival is at least 24 months

Exclusion Criteria:

  1. Concomitant disease of another heart valve or the aorta that requires either transcatheter or surgical intervention
  2. Any condition that is considered a contraindication for placement of a bioprosthetic aortic valve (e.g. patient requires a mechanical aortic valve)
  3. Aortic stenosis secondary to a bicuspid aortic valve (except for the bicuspid valve cohort)
  4. End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine clearance <20 cc/min
  5. Left ventricular ejection fraction <20%
  6. Recent (<6 months) history of stroke or transient ischemic attack
  7. Symptomatic carotid or vertebral artery disease, or recent (<6 weeks) surgical or endovascular treatment of carotid stenosis
  8. Any contraindication to oral antiplatelet or anticoagulation therapy following the procedure
  9. Severe coronary artery disease that is unrevascularized
  10. Recent (<30 days) acute myocardial infarction
  11. Patient cannot undergo transfemoral TAVR for anatomic reasons (as determined by supplemental imaging studies); this would include inadequate size of iliofemoral access vessels or an aortic annulus size that is not accommodated by the commercially available valves
  12. Any comorbidity not captured by the STS score that would make SAVR high risk, as determined by a cardiothoracic surgeon who is a member of the heart team; this includes:
    1. porcelain or severely atherosclerotic aorta
    2. frailty
    3. hostile chest
    4. IMA or other conduit either crosses midline of sternum or is adherent to sternum
    5. severe pulmonary hypertension (PA systolic pressure > 2/3 of systemic pressure)
    6. severe right ventricular dysfunction
  13. Ongoing sepsis or infective endocarditis
  14. Recent (<30 days) or ongoing bleeding that would preclude treatment with anticoagulant or antiplatelet therapy, including recent gastrointestinal bleeding
  15. Uncontrolled atrial fibrillation (resting heart rate >120 beats per minute)
  16. Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) <750 cc
  17. Liver failure with Childs class C or D
  18. Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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