Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2019-09-17
2022-07-20
Brief Summary
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Detailed Description
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Study type: Observational
Estimated Enrollment: 75 patients
Allocation: Non - randomized, all comers
Primary Purpose: Treatment
Observational Model: Case-Control
Condition or disease: Aortic valve stenosis
Intervention/Treatment: Device: Boston Scientific ACURATE neoTM transfemoral TAVI system
Time Perspective: Prospective
Participating centers: Hippokration Hospital (Athens, Greece), Silesian Center for Heart Diseases (Zabrze, Poland), Athens Naval Hospital (Athens, Greece). It is possible that the number of the participating center may change.
Methods: Patients treated with the Boston Scientific ACURATE NEO/TF system will be prospectively. All patients will be followed for at least 30 days.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients treated with Medtronic CoreValve/ Evolut R/Pro
TAVI patients treated with Medtronic CoreValve /Evolut R - Evolut PRO Transcatheter Heart Valves, participated in the DIRECT trial
Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro
Transcatheter implantation of the heart valve device Medtronic Evolut R/Pro in patients suffering from severe aortic stenosis and are candidates for this operation
Patients treated with ACURATE neo/TF
TAVI patients treated with ACURATE neo/TF Transcatheter Heart Valve recruited prospectively.
Transcatheter Aortic Valve Implantation with ACURATE NEO/TF
Transcatheter implantation of the heart valve device ACURATE neo/TF in patients suffering from severe aortic stenosis and are candidates for this operation
Interventions
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Transcatheter Aortic Valve Implantation with ACURATE NEO/TF
Transcatheter implantation of the heart valve device ACURATE neo/TF in patients suffering from severe aortic stenosis and are candidates for this operation
Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro
Transcatheter implantation of the heart valve device Medtronic Evolut R/Pro in patients suffering from severe aortic stenosis and are candidates for this operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class \> I, angina or syncope)
* Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of a cardiologist and surgeon or as confirmed by a logistic EuroSCORE I ≥ 20% and / or EuroSCORE II ≥ 7% STS score ≥ 8% OR
* Over 80 years old OR
* Over 65 years old with 1 or 2 (but not more than two) from the following criteria:
Liver cirrhosis (Class A or B). Pulmonary insufficiency: VMS\<1 liter. Previous heart surgery (CABG, vascular surgery). Porcelain aorta. Pulmonary artery systolic pressure \>60 mmHg and high risk for heart surgery. Relapsing pulmonary embolism. Right ventricular insufficiency. Thoracic wall injuries that contraindicate an open heart surgery. History of radiation therapy of the mediastinum. Connective tissue disease that contraindicates an open heart surgery. Frailty/cachexia.
* Aortic valve diameter of ≥20mm and ≤2 9mm as measured by echo.
* Ascending aorta diameter ≤ 43 mm at the sinotubular junction.
* Arterial aorto-iliac-femoral axis suitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter ≥ 6mm)
* Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
* Patient has given written consent to participate in the trial
Exclusion Criteria
* Ongoing sepsis, including active endocarditis.
* Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to Heart Team assessment.
* Echocardiographic evidence of LV or LA thrombus.
* Mitral or tricuspid valve insufficiency (\> grade II).
* Previous aortic valve replacement (mechanical or bioprosthetic).
* Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
* Patients with:
Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a transcatheter sheath.
OR Symptomatic carotid or vertebral artery disease (\> 70% stenosis).
* The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.
* Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
* Creatinine clearance \< 20 ml/min.
* Active gastritis or gastrointestinal ulcer.
* Pregnancy.
* Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%.
* Unicuspid aortic valve.
* Mixed aortic valve disease (aortic stenosis and aortic regurgitation\> 2+).
* Liver failure (Child-Pugh class C).
* Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
* Extreme aortic valve calcification and calcific asymmetry (Agatston score: grade 4 AgS\>5000 AU).
* Aortic valve area of \< 0.4 cm2.
18 Years
ALL
No
Sponsors
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Naval Hospital, Athens
OTHER
Silesian Centre for Heart Diseases
OTHER
University General Hospital of Heraklion
OTHER
Interbalkan Medical Center, Thessaloniki, Greece
UNKNOWN
National and Kapodistrian University of Athens
OTHER
Responsible Party
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Konstantinos Toutouzas
Professor
Principal Investigators
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Konstantinos P Toutouzas, Professor
Role: STUDY_DIRECTOR
Professor of Cardiology
Locations
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Hippocration Hospital First Department of Cardiology, University of Athens, Medical School
Athens, , Greece
Countries
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References
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Arora S, Strassle PD, Ramm CJ, Rhodes JA, Vaidya SR, Caranasos TG, Vavalle JP. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Lower Surgical Risk Scores: A Systematic Review and Meta-Analysis of Early Outcomes. Heart Lung Circ. 2017 Aug;26(8):840-845. doi: 10.1016/j.hlc.2016.12.003. Epub 2017 Jan 24.
Adams HSL, Ashokkumar S, Newcomb A, MacIsaac AI, Whitbourn RJ, Palmer S. Contemporary review of severe aortic stenosis. Intern Med J. 2019 Mar;49(3):297-305. doi: 10.1111/imj.14071.
Saikrishnan N, Kumar G, Sawaya FJ, Lerakis S, Yoganathan AP. Accurate assessment of aortic stenosis: a review of diagnostic modalities and hemodynamics. Circulation. 2014 Jan 14;129(2):244-53. doi: 10.1161/CIRCULATIONAHA.113.002310. No abstract available.
4. Piérard L. Transcatheter aortic valve implantation: indications. E-Journal of Cardiology Practice [Internet]. 2016 5 May 2019 [cited 2019 5 May 2019]; Volume 14 Available from: https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-14/transcatheter-aortic-valve-implantation-indications
Mollmann H, Diemert P, Grube E, Baldus S, Kempfert J, Abizaid A. Symetis ACURATE TF aortic bioprosthesis. EuroIntervention. 2013 Sep 10;9 Suppl:S107-10. doi: 10.4244/EIJV9SSA22. No abstract available.
Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1359-1367. doi: 10.1016/j.jcin.2015.05.015.
Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014.
Toutouzas K, Benetos G, Voudris V, Drakopoulou M, Stathogiannis K, Latsios G, Synetos A, Antonopoulos A, Kosmas E, Iakovou I, Katsimagklis G, Mastrokostopoulos A, Moraitis S, Zeniou V, Danenberg H, Vavuranakis M, Tousoulis D. Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial. JACC Cardiovasc Interv. 2019 Apr 22;12(8):767-777. doi: 10.1016/j.jcin.2019.02.005. Epub 2019 Mar 27.
Pagnesi M, Kim WK, Conradi L, Barbanti M, Stefanini GG, Zeus T, Pilgrim T, Schofer J, Zweiker D, Testa L, Taramasso M, Hildick-Smith D, Abizaid A, Wolf A, Van Mieghem NM, Sedaghat A, Wohrle J, Khogali S, Van der Heyden JAS, Webb JG, Estevez-Loureiro R, Mylotte D, MacCarthy P, Brugaletta S, Hamm CW, Bhadra OD, Schafer U, Costa G, Tamburino C, Cannata F, Reimers B, Veulemans V, Asami M, Windecker S, Eitan A, Schmidt A, Bianchi G, Bedogni F, Saccocci M, Maisano F, Alsanjari O, Siqueira D, Jensen CJ, Naber CK, Ziviello F, Sinning JM, Seeger J, Rottbauer W, Brouwer J, Alenezi A, Wood DA, Tzalamouras V, Regueiro A, Colombo A, Latib A. Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves. JACC Cardiovasc Interv. 2019 Mar 11;12(5):433-443. doi: 10.1016/j.jcin.2018.11.036.
Other Identifiers
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DIRECT II
Identifier Type: -
Identifier Source: org_study_id