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

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ClinicalTrials.gov Identifier: NCT04517955
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dimitris Tousoulis, University of Athens

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 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.

Condition or disease Intervention/treatment
Transcatheter Aortic Valve Replacement Device: Transcatheter Aortic Valve Implantation (TAVI)

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 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)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : March 30, 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Transcatheter Aortic Valve Implantation (TAVI)
    Transcatheter Aortic Valve Implantation with Evolut R or Evolut Pro
    Other Name: Transcatheter Aortic Valve Replacement (TAVR)


Primary Outcome Measures :
  1. Device success (VARC-2 criteria) [ Time Frame: 30 days ]
    1. Absence of procedural mortality
    2. Correct positioning of the prosthetic heart valve into the proper anatomical location
    3. Intended performance of the prosthetic heart valve (mean aortic valve gradient<20mmHg or peak velocity < 3m/s, and no moderate or severe prosthetic valve regurgitation) as assessed with 24h post implantation and pre-discharge echocardiogram


Secondary Outcome Measures :
  1. Rate of All-cause mortality [ Time Frame: 30 days ]
    Early Safety

  2. Rate of All stroke (disabling and non-disabling) [ Time Frame: 30 days ]
    Early Safety

  3. Rate of Life-threatening bleeding [ Time Frame: 30 days ]
    Early Safety

  4. Rate of Acute Kidney Injury-Stage 2 or 3 (including renal replacement therapy) [ Time Frame: 30 days ]
    Early Safety

  5. Rate of Coronary artery obstruction requiring intervention [ Time Frame: 30 days ]
    Early Safety

  6. Rate of Major vascular complication [ Time Frame: 30 days ]
    Early Safety

  7. Rate of Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR) [ Time Frame: 30 days ]
    Early Safety

  8. Rate of New pacemaker implantation [ Time Frame: 30 days ]
    Early Safety

  9. Rate of All-cause mortality [ Time Frame: after 30 days and up to 2 years ]
    Clinical Efficacy

  10. Rate of All stroke (disabling and non-disabling) [ Time Frame: after 30 days and up to 2 years ]
    Clinical Efficacy

  11. Rate of Hospitalizations for valve-related symptoms or worsening congestive heart failure NYHA class III or IV [ Time Frame: after 30 days and up to 2 years ]
    Clinical Efficacy

  12. Rate of Valve related dysfunction [ Time Frame: after 30 days and up to 2 years ]
    Mean aortic valve gradient >=20mmHg, Effective orifice area (EOA)<=0.9-1.1cm2, and/or Dimensionless Valve Index (DVI)<0.35 m/s and/or moderate or severe prosthetic valve regurgitation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients 75-79 years old who have symptomatic severe aortic stenosis at intermediate surgical risk defined by a Society of Thoracic Surgeons (STS) mortality risk of >=4% and <=8%, will be presented to the Heart Team for inclusion in the trial.

Patients will have risk factors not captured by traditional risk scores

Criteria

Inclusion Criteria:

  1. Age 75-79
  2. Subject must have Society of Thoracic Surgeons (STS) score >=4% and <=8%
  3. 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

  4. 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)
  5. Critical aortic valve area defined as an initial aortic valve area of <=1cm2 or aortic valve index <0.6cm2/m2
  6. In presence of normal left ventricular function:

    1. Mean gradient >40mmHg OR Vmax>4m/sec OR
    2. 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
  7. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater
  8. The subject is suitable for direct TAVI not preceded by balloon valvuloplasty according to the judgment of the treating physicians
  9. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Exclusion Criteria:

  1. Hypersensitivity or contraindication to aspirin, heparin, clopidogrel, coumadin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
  2. Blood dyscrasias as defined: leukopenia (WBC<1000/mm3), thrombocytopenia (platelet count <50.000cells/mm3), history of bleeding diathesis or coagulopathy;
  3. Ongoing sepsis, including active endocarditis
  4. Any condition considered a contraindication to extracorporeal assistance;
  5. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks prior treatment
  6. Cardiogenic shock manifested by low cardiac output, vasopressor dependence or mechanical hemodynamic support;
  7. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  8. Active gastrointestinal (GI) bleeding within the past 3 months
  9. Subject refuses a blood transfusion;
  10. 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);
  11. Multivessel coronary artery disease with a Syntax score >22
  12. Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions
  13. 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;
  14. Currently participating in an investigational drug or another device trial (excluding registries)
  15. Evidence of an acute myocardial infarction <=30 days before the index procedure
  16. Need for emergency surgery for any reason
  17. Uncontrolled atrial fibrillation

    Anatomical Exclusion Criteria:

  18. Native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging;
  19. Mixed aortic valve disease [aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+]
  20. Severe mitral or severe tricuspid regurgitation
  21. Severe mitral stenosis;
  22. Hypertrophic obstructive cardiomyopathy
  23. Echocardiographic or Multislice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus or vegetation
  24. 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)
  25. Congenital bicuspid or unicuspid valve verified by echocardiography Vascular Exclusion Criteria
  26. Transarterial access not able to accommodate an 16 French sheath

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517955


Contacts
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Contact: Dimitris Tousoulis, Prof +302132088099 tousoulis@med.uoa.gr
Contact: Konstantinos Toutouzas, Prof +302132088099 ktoutouz@med.uoa.gr

Locations
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Greece
Cardiology Department, Hippokration Hospital Not yet recruiting
Athens, Greece, 11527
Contact: Dimitris Syrseloudis, MD         
First Department of Cardiology, National & Kapodistrian University of Athens Recruiting
Athens, Greece, 11527
Contact: Konstantinos Toutouzas, Prof    +302132088099    ktoutouz@med.uoa.gr   
Onassis Cardiac Surgery Center Not yet recruiting
Athens, Greece, 17674
Contact: Vassilios Voudris, MD         
University Hospital of Heraklion Not yet recruiting
Heraklion, Greece, 71110
Contact: Fragkiskos Parthenakis, Prof         
University Hospital of Ioannina Not yet recruiting
Ioannina, Greece, 45500
Contact: Lampros Michalis, Prof         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Dimitris Tousoulis, Prof First Department of Cardiology, University of Athens
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Responsible Party: Dimitris Tousoulis, Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT04517955    
Other Study ID Numbers: 088891/2019
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dimitris Tousoulis, University of Athens:
aortic stenosis
TAVI
Evolut R
Evolut Pro