The PROGRESS Trial: A Prospective Randomized Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Moderate Aortic Stenosis
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Age: Between 65 - 115 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants with moderate, calcific aortic stenosis (AS)
- Subject meets at least one of the following criteria
- Valve-related symptoms
- LVEF <60%
- Diastolic dysfunction (= Grade 2)
- Stroke volume index < 35 mL/m2
- NT-Pro BNP > 3x normal
- Elevated calcium score
- Able to provide written informed consent
You may not be eligible for this study if the following are true:
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- Native aortic annulus size unsuitable for the THV
- Anatomical characteristics that would preclude safe placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid or non-calcified
- Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
- Pre-existing mechanical or bioprosthetic aortic valve
- Severe aortic regurgitation
- Prior balloon aortic valvuloplasty (BAV) to treat severe AS
- LVEF <20%
- Left ventricular outflow tract (LVOT) calcification
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
- Hypertrophic cardiomyopathy with sub-valvular obstruction
- Any concomitant valvular disease requiring surgical or transcatheter intervention
- Significant untreated coronary artery disease requiring revascularization
- Severe chronic obstructive pulmonary disease or currently on home oxygen
- Liver disease
- Renal insufficiency and/or renal replacement therapy
- Significant frailty
- Leukopenia, anemia, thrombocytopenia
- Inability to tolerate or condition precluding treatment with antithrombotic therapy
- Hypercoagulable state or other condition that increases risk of thrombosis
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Subject refuses blood products
- Body mass index (BMI) > 50 kg/m2
- Estimated life expectancy < 24 months
- Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Participating in another drug or device study that has not reached its primary endpoint
- Subject considered to be part of a vulnerable population
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.