Status:
UNKNOWN
TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores
Lead Sponsor:
University of Athens
Conditions:
Transcatheter Aortic Valve Replacement
Eligibility:
All Genders
18+ years
Brief Summary
Single arm, observational trial of Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic Evolut R and Evolut Pro The primary objective of this trial is to evaluate device success of TAVI w...
Detailed Description
The purpose of this study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in septuagenarians with severe, symptomatic Aortic Stenosis (AS) and risk factors ...
Eligibility Criteria
Inclusion
- Age 75-79
- Subject must have Society of Thoracic Surgeons (STS) score \>=4% and \<=8%
- Subject must have at least one from the risk factors presented below:
- i. Severely atherosclerotic or porcelain aorta ii. Internal Mammary Artery (IMA) or other conduit(s) crossing midline and/or adherent to posterior table of sternum iii. Pre-existing mechanical valve in any other position iv. Severe right ventricular dysfunction v. Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities, evidence of severe radiation damage, history of multiple recurrent pleural effusions causing internal adhesions) vi. Severe liver disease/cirrhosis vii. Frailty viii. Malignancy with life expectancy that exceeds 24 months ix. Renal replacement therapy with creatinine levels \>200mmol/L or 2.26 mg/dl
- Heart team consisting of at least one interventional cardiologist and one cardiac surgeon agree on indication and treatment proposal, based on their clinical judgment (including anatomy assessment, risk factors, etc)
- Critical aortic valve area defined as an initial aortic valve area of \<=1cm2 or aortic valve index \<0.6cm2/m2
- In presence of normal left ventricular function:
- Mean gradient \>40mmHg OR Vmax\>4m/sec OR
- In presence of low flow, low gradient severe AS, a dobutamine stress echo must be conducted that demonstrates presence of contractile reserve defined as follows \>=20% increase in stroke volume and mean gradient \>40mmHg
- Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater
- The subject is suitable for direct TAVI not preceded by balloon valvuloplasty according to the judgment of the treating physicians
- The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.
Exclusion
- Hypersensitivity or contraindication to aspirin, heparin, clopidogrel, coumadin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
- Blood dyscrasias as defined: leukopenia (WBC\<1000/mm3), thrombocytopenia (platelet count \<50.000cells/mm3), history of bleeding diathesis or coagulopathy;
- Ongoing sepsis, including active endocarditis
- Any condition considered a contraindication to extracorporeal assistance;
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks prior treatment
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence or mechanical hemodynamic support;
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Active gastrointestinal (GI) bleeding within the past 3 months
- Subject refuses a blood transfusion;
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
- Multivessel coronary artery disease with a Syntax score \>22
- Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions
- Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consentor adherence to the protocol required follow-up exams;
- Currently participating in an investigational drug or another device trial (excluding registries)
- Evidence of an acute myocardial infarction \<=30 days before the index procedure
- Need for emergency surgery for any reason
- Uncontrolled atrial fibrillation
- Anatomical
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04517955
Start Date
July 1 2020
End Date
March 30 2025
Last Update
August 19 2020
Active Locations (5)
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1
Cardiology Department, Hippokration Hospital
Athens, Greece, 11527
2
First Department of Cardiology, National & Kapodistrian University of Athens
Athens, Greece, 11527
3
Onassis Cardiac Surgery Center
Athens, Greece, 17674
4
University Hospital of Heraklion
Heraklion, Greece, 71110