TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores

  • STATUS
    Recruiting
  • End date
    Mar 30, 2025
  • participants needed
    80
  • sponsor
    University of Athens
Updated on 24 January 2021
stenosis
stroke
aortic valve stenosis
stress echo

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 with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.

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 for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.

The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.

The secondary objective is to assess early safety (at 30 days) and clinical efficacy (after 30 days) of the TAVI procedure.

Exploratory objective: comparative health economics in septuagenarians with symptomatic severe aortic stenosis and intermediate surgical risk treated with Transcatheter Aortic Valve Implantation (TAVI) vs Surgical Aortic Valve Replacement (SAVR) (matched historic cohort)

Details
Condition Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement, TAVI, transcatheter aortic valve implant
Treatment Transcatheter aortic valve implantation (TAVI)
Clinical Study IdentifierNCT04517955
SponsorUniversity of Athens
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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 Exclusion Criteria
\. Native aortic annulus size <18mm or >30mm per the baseline diagnostic
imaging
\. Mixed aortic valve disease [aortic stenosis and aortic regurgitation with
predominant aortic regurgitation (3-4+]
\. Severe mitral or severe tricuspid regurgitation
\. Severe mitral stenosis
\. Hypertrophic obstructive cardiomyopathy
\. Echocardiographic or Multislice Computed Tomography (MSCT) evidence of
intracardiac mass, thrombus or vegetation
\. Anatomy of the aortic root and ascending aorta not suitable for TAVI with
Evolut R or Evolut Pro system (aortic root angulation >70 degrees for femoral
and left subclavian access or >30 degrees for right subclavian access)
\. Congenital bicuspid or unicuspid valve verified by echocardiography
Vascular Exclusion Criteria
\. Transarterial access not able to accommodate an 16 French sheath
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