Impact of Predilatation Between Self-expanding Valves

NCT04157920 | Completed

• 1 other identifier: DIRECT II
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, prospective, non-randomized, trial evaluating the safety and clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves, implanted in patients with severe aortic stenosis and the impact of predilatation in comparison with the Medtronic CoreValve EvolutT R/PRO systems from the DIRECT trial.

Conditions

Aortic Stenosis

Keywords

Aortic stenosis; DIRECT; ACURATE; TAVI; TAVR; transcatheter; valve

Outcome Measures

Primary Outcomes (1)

• Device success

  ACURATE NEO/TF device implantation success rates, as designated by the VARC-2 criteria

  30 days

Secondary Outcomes (9)

• All cause Mortality

  30 days

• All stroke

  30 days

• New pacemaker implantation

  30 days

• Major Vascular complications

  30 days

• Echocardiographic endpoint

  30 days

Study Arms (2)

Patients treated with Medtronic CoreValve/ Evolut R/Pro

OTHER

TAVI patients treated with Medtronic CoreValve /Evolut R - Evolut PRO Transcatheter Heart Valves, participated in the DIRECT trial

Device: Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro

Patients treated with ACURATE neo/TF

ACTIVE COMPARATOR

TAVI patients treated with ACURATE neo/TF Transcatheter Heart Valve recruited prospectively.

Device: Transcatheter Aortic Valve Implantation with ACURATE NEO/TF

Interventions

Transcatheter Aortic Valve Implantation with ACURATE NEO/TF DEVICE

Transcatheter implantation of the heart valve device ACURATE neo/TF in patients suffering from severe aortic stenosis and are candidates for this operation

Also known as: Boston Scientific ACURATE neo/TF

Patients treated with ACURATE neo/TF

Transcatheter Aortic Valve Implantation with Medtronic CoreValve /Evolut R/Pro DEVICE

Transcatheter implantation of the heart valve device Medtronic Evolut R/Pro in patients suffering from severe aortic stenosis and are candidates for this operation

Also known as: Medtronic CoreValve /Evolut R/Pro

Patients treated with Medtronic CoreValve/ Evolut R/Pro

Eligibility Criteria

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

You may qualify if:

• Patient with severe symptomatic aortic stenosis defined by a mean aortic gradient \> 40 mmHg or peak jet velocity \> 4.0 m/s or an aortic valve area (AVA) \< 1cm2 or AVA indexed to body surface area (BSA) of \<0.6 cm2/m2
• 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

You may not qualify if:

• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin and bivalirudin, ticlodipine and clopidogrel, nitinol (titanium or nickel), contrast media
• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Naval Hospital, Athens: collaborator
• Silesian Centre for Heart Diseases: collaborator
• University General Hospital of Heraklion: collaborator
• Interbalkan Medical Center, Thessaloniki, Greece: collaborator

Study Sites (1)

Hippocration Hospital First Department of Cardiology, University of Athens, Medical School

Athens, 11527, Greece

Location

Related Publications (9)

• 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.

  PMID: 28169084 BACKGROUND

• 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.

  PMID: 30091235 BACKGROUND

• 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.

  PMID: 24421359 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24025946 BACKGROUND

• 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.

  PMID: 26315740 BACKGROUND

• 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.

  PMID: 29348010 BACKGROUND

• 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.

  PMID: 30928442 BACKGROUND

• 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.

  PMID: 30846081 BACKGROUND

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

• Konstantinos P Toutouzas, Professor

  Professor of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients undergoing TAVR for severe aortic stenosis with two different transcatheter devices. One arm received Medtronic Evolut R/Pro. The other is receiving Boston Scientific ACURATE NEO/TF

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 8, 2019
• Study Start: September 17, 2019
• Primary Completion: April 1, 2021
• Study Completion: July 20, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)