Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis

Completed · Not applicable

Conditions studied: Aortic Stenosis

In brief

To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

Key facts

Study ID

NCT02628899

Run by

Medstar Health Research Institute

People needed

277

Starts

2016-01-01

Expected to finish

2023-01-01

Last updated by the study team

2024-05-16

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, 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
• 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.
• The Heart Team agrees that transfemoral TAVR is anatomically feasible, based upon multislice CT measurements
• Procedure status is elective
• Expected survival is at least 24 months
• For the bicuspid cohort only:
• Aortic Stenosis of a bicuspid aortic valve

You may not qualify if…

• 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 (except for the bicuspid valve cohort)
• 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 or transient ischemic attack
• 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
• 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
• IMA 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
• Recent (<30 days) or ongoing bleeding that would preclude treatment with anticoagulant or antiplatelet therapy, including recent gastrointestinal bleeding
• Uncontrolled atrial fibrillation (resting heart rate >120 beats per minute)
• Severe chronic obstructive pulmonary disease, as demonstrated by forced expiratory volume (FEV1) <750 cc
• Liver failure with Childs class C or D

Where it is running

• Sutter Health System — Sacramento, California, United States
• Foundation for Cardiovascular Medicine — San Diego, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• WellStar Kennestone Hospital — Marietta, Georgia, United States
• Maine Medical Center — Portland, Maine, 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
• Miriam Hospital — Providence, Rhode Island, United States
• Henrico Doctors' Hospital — Richmond, Virginia, United States
• VCU Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.