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

NCT04517955 | Unknown

• 1 other identifier: 088891/2019
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 5

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.

Conditions

Transcatheter Aortic Valve Replacement

Keywords

aortic stenosis; TAVI; Evolut R; Evolut Pro

Outcome Measures

Primary Outcomes (1)

• Device success (VARC-2 criteria)

  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

  30 days

Secondary Outcomes (12)

• Rate of All-cause mortality

  30 days

• Rate of All stroke (disabling and non-disabling)

  30 days

• Rate of Life-threatening bleeding

  30 days

• Rate of Acute Kidney Injury-Stage 2 or 3 (including renal replacement therapy)

  30 days

• Rate of Coronary artery obstruction requiring intervention

  30 days

Interventions

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

Transcatheter Aortic Valve Implantation with Evolut R or Evolut Pro

Also known as: Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (5)

Cardiology Department, Hippokration Hospital

Athens, 11527, Greece

NOT YET RECRUITING

First Department of Cardiology, National & Kapodistrian University of Athens

Athens, 11527, Greece

RECRUITING

Onassis Cardiac Surgery Center

Athens, 17674, Greece

NOT YET RECRUITING

University Hospital of Heraklion

Heraklion, 71110, Greece

NOT YET RECRUITING

University Hospital of Ioannina

Ioannina, 45500, Greece

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Dimitris Tousoulis, Prof

  First Department of Cardiology, University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitris Tousoulis, Prof

CONTACT

+302132088099; tousoulis@med.uoa.gr

Konstantinos Toutouzas, Prof

CONTACT

+302132088099; ktoutouz@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 19, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: March 30, 2025
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

GR (5)