PRospective Evaluation Complementing Investigation With Acurate Neo Device

NCT03846557 | Completed DMC

• 1 other identifier: PRECISA -EPIC 11
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.

Conditions

Aortic Stenosis

Keywords

TAVI; Valve

Outcome Measures

Primary Outcomes (2)

• Device success of implantation

  Proportion of patients with device success of implantation defined as: * absence of procedural mortality AND * correct positioning of a single prosthetic heart valve into the proper anatomical location AND * no prosthesis - patient mismatch AND * mean aortic valve gradient \<20 mmHg, AND * no moderate or severe prosthetic valve regurgitation

  7 days

• Cardiovascular death

  Cumulative incidence of a combination of all cause Cardiovascular death

  30 days post-index procedure

Secondary Outcomes (5)

• Assessment of early safety

  30 days

• Assessment of time-related valve safety

  30 days

• Assesment of NYHA (New York Heart Association ) classification

  7 days, 30 days, 12 month

• Assessment of mean aortic gradient post-implantation

  up to one year

• Death during the hospitalization of the patient

  date of procedure till date of estimated discharge, assessed up to two weeks

Study Arms (1)

Treatment

Transcatheter Aortic Valve Implantation (TAVI) Device

Device: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

Implantation of the Acurate Neo Transcatheter Heart Valve

Treatment

Eligibility Criteria

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

Study Population

Patients with severe aortic stenosis with indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.

You may qualify if:

• ≥18 years.
• Severe aortic stenosis with indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.
• Has signed the Patient Informed Consent Form.

You may not qualify if:

• Severe aortic stenosis without indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (10)

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico de San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital Universitari I Politècnic de La Fé

Valencia, 46026, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Related Publications (10)

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 BACKGROUND

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 BACKGROUND

• Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 Sep 4;371(10):967-8. doi: 10.1056/NEJMc1408396. No abstract available.

  PMID: 25184874 BACKGROUND

• Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.

  PMID: 27040324 BACKGROUND

• Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.

  PMID: 28304219 BACKGROUND

• Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Sondergaard L. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015 May 26;65(20):2184-94. doi: 10.1016/j.jacc.2015.03.014. Epub 2015 Mar 15.

  PMID: 25787196 BACKGROUND

• Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.

  PMID: 28886619 BACKGROUND

• Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

  PMID: 12831818 BACKGROUND

• Pesarini G, Lunardi M, Piccoli A, Gottin L, Prati D, Ferrero V, Scarsini R, Milano A, Forni A, Faggian G, Ribichini F. Effectiveness and Safety of Transcatheter Aortic Valve Implantation in Patients With Pure Aortic Regurgitation and Advanced Heart Failure. Am J Cardiol. 2018 Mar 1;121(5):642-648. doi: 10.1016/j.amjcard.2017.11.042. Epub 2017 Dec 11.

  PMID: 29329825 BACKGROUND

• Tebar D, Carrillo X, Garcia Del Blanco B, Gomez-Hospital JA, Nombela L, Molina E, Galeote G, Vilalta V, Serra-Garcia V, Carol GM, Jimenez-Valero S, Fernandez-Nofrerias E, Calabuig-Goena A, Jurado-Roman A, Sanchez-Recalde A, Velasco MF, Bosca L, Moreno R. Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry. Catheter Cardiovasc Interv. 2024 May;103(6):1015-1022. doi: 10.1002/ccd.31032. Epub 2024 Apr 5.

  PMID: 38577931 DERIVED

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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 19, 2019
• Study Start: May 20, 2019
• Primary Completion: September 2, 2021
• Study Completion: October 2, 2021
• Last Updated: June 18, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)