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.

  • STATUS
    Recruiting
  • sponsor
    MedStar Cardiovascular Research Institute
Updated on 23 November 2020

Summary

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.

Description

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. Subjects in this trial will be compared to similar patients that have already undergone surgical aortic valve replacement. The information from this trial will be used to inform future studies of transcatheter aortic valves in low-risk patients.

Candida Barlow MSN, RN
Director, St. John Clinical Research Institute
1725 E. 19th St. Suite 701
Tulsa, OK 74104
Office: 918-744-3426 Fax: 918-403-0018
Email: candida.barlow@sjmc.org

Details
Clinical Study IdentifierTX145734
SponsorMedStar Cardiovascular Research Institute
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 65 yrs and 0 yrs?
Gender: Male or Female
Severe, degenerative AS, defined as
mean aortic valve gradient ≥40 mm Hg OR Vmax ≥4 m/sec AND
calculated aortic valve area ≤1.0 cm 2 OR aortic valve area index ≤0.6 cm 2 /m 2
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

Exclusion Criteria

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)
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
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
Pre-procedure shock, inotropes, mechanical assist device, or cardiac arrest
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