Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 277
- 试验地点
- 22
- 主要终点
- Life Threatening and Major Bleeding
研究概览
简要总结
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).
详细描述
Trial Objectives: 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).
Methodology: This is a multicenter, prospective trial of TAVR in low-risk patients at up to twelve sites in the United States. The trial will have three arms. The first will comprise 200 patients undergoing transfemoral TAVR. The second arm will comprise200 closely matched historical controls who underwent isolated bioprosthetic SAVR.
Historical controls will be selected from among patients at the same site who have undergone isolated bioprosthetic SAVR within the previous 36 months. TAVR patients will then be matched to SAVR patients using STS database variables to perform propensity matching, including (but not limited to) age, gender, race, ethnicity, STS score, and valve prosthesis size. Once the historical matched controls are identified, detailed chart review will abstract in-hospital and 30-day outcomes for the SAVR cohort.
The third arm of the trial will comprise a registry of TAVR in up to 100 low-risk patients with bicuspid aortic valve. The results from the registry arm will be analyzed independently.
Primary Efficacy Endpoint: All-cause mortality at 30 days following transfemoral TAVR vs. bioprosthetic SAVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
- •Known allergy to warfarin or aspirin
结局指标
主要结局
Life Threatening and Major Bleeding
时间窗: 30 days
Major Vascular Complications
时间窗: 30 days
Composite of major adverse events at 30 days
时间窗: 30 days
Composite of major adverse events at 30 days 1. all-cause mortality 2. stroke 3. spontaneous myocardial infarction (MI) 4. reintervention: defined as any cardiac surgery or percutaneous reintervention that repairs, alters, or replaces a previously implanted aortic valve 5. VARC life-threatening bleeding 6. Increase in serum creatinine to ≥300% (\>3x increase compared to baseline) OR serum creatinine ≥4.0 mg/dL with an acute increase ≥0.5 mg/dL OR new requirement for dialysis 7. coronary artery obstruction requiring percutaneous or surgical intervention 8. VARC major vascular complication 9. cardiac tamponade 10. cardiac perforation 11. pericarditis 12. mediastinitis 13. hemolysis 14. infective endocarditis 15. moderate or severe aortic insufficiency 16. significant aortic stenosis 17. permanent pacemaker implantation
All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR
时间窗: 30 days following transfemoral TAVR vs. bioprosthetic SAVR
All-cause mortality at 30 days following transfemoral TACR vs. bioprosthetic SAVR
All Stroke (disabling and non-disabling, ischemic and hemorrhagic
时间窗: 30 Days
All Cause Mortality
时间窗: 30 days
Hospitalizations for valve-related symptoms or worsening congestive heart failure
时间窗: 30 days
次要结局
- VARC - 2 Device Success(30 days)
- composite of all-cause mortality, stroke, spontaneous MI, re-intervention(30 days, 6 months, 12 months, and 2,3,4 and 5 years)