Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement

Status unconfirmed · Not applicable

Conditions studied: Aortic Stenosis

In brief

100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.

Key facts

Study ID

NCT03557242

Run by

Medstar Health Research Institute

People needed

124

Starts

2018-07-05

Expected to finish

2023-07-30

Last updated by the study team

2022-01-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe, degenerative AS, defined as:
• Mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND
• Calculated aortic valve area ≤1.0 cm2 OR aortic valve area index ≤0.6 cm2/m2
• Symptomatic AS, defined as a history of at least one of the following:
• Dyspnea that qualifies at New York Heart Association (NYHA) class II or greater
• Angina pectoris
• Cardiac syncope
• The Heart Team agrees that the patient is low-risk, quantified by an estimated risk of death ≤3% by the calculated STS score for operative mortality at 30 days; AND agrees that SAVR would be an appropriate therapy if offered
• A surgeon who is experienced in Surgical Aortic Valve Replacement (SAVR) has spoken with the patient in person and stipulates that the patient understands his/her alternatives for FDA approved therapy, including open heart surgery to replace their aortic valve
• The institutional Heart Team determines that transfemoral TAVR is appropriate
• Aortic valve anatomy and dimensions suitable for TAVR using a commercially available valve
• Iliofemoral artery anatomy and dimensions suitable for transfemoral TAVR using a commercially available valve and delivery system
• Procedure status is elective
• Expected survival is at least 24 months

You may not qualify if…

• Subject unable or unwilling to give informed consent
• Concomitant disease of another heart valve or the aorta that requires either transcatheter or surgical intervention
• Any condition that is considered a contraindication for placement of a bioprosthetic aortic valve (e.g. patient requires a mechanical aortic valve)
• Aortic stenosis secondary to a bicuspid aortic valve
• Prior bioprosthetic surgical aortic valve replacement
• Mechanical heart valve in another position
• End-stage renal disease requiring hemodialysis or peritoneal dialysis, or a creatinine clearance <20 cc/min
• Left ventricular ejection fraction <20%
• Recent (<6 months) history of stroke
• Symptomatic carotid or vertebral artery disease, or recent (<6 weeks) surgical or endovascular treatment of carotid stenosis
• Any contraindication to oral antiplatelet or anticoagulation therapy following the procedure, including recent or ongoing bleeding, or HASBLED score >3 (Table 2 - HASBLED scoring system)
• Severe coronary artery disease that is unrevascularized
• Recent (<30 days) acute myocardial infarction
• 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
• 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:
• Porcelain or severely atherosclerotic aorta
• Frailty
• Hostile chest
• Internal mammary artery or other conduit either crosses midline of sternum or is adherent to sternum
• Severe pulmonary hypertension (PA systolic pressure > 2/3 of systemic pressure)
• Severe right ventricular dysfunction
• Ongoing sepsis or infective endocarditis
• Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) <750 cc
• Liver failure with Childs class C or D
• Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest

Where it is running

• Foundation for Cardiovascular Medicine — San Diego, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Stony Brook Hospital — Stony Brook, New York, United States
• St. John Health System — Tulsa, Oklahoma, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Henrico Doctors' Hospital — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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