PRospective Evaluation Complementing Investigation With Acurate Neo Device

Aortic Stenosis Clinical Trial

— PRECISA  

Official title:

PRospective Evaluation Complementing Investigation With Acurate Neo Device

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03846557
• Other study ID #: PRECISA -EPIC 11
• Status: Active, not recruiting
• Start date: May 20, 2019
• Est. completion date: November 2, 2022

Study information

• Verified date: January 2022
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• Transcatheter Aortic Valve Implantation (TAVI)
Implantation of the Acurate Neo Transcatheter Heart Valve

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias I Pujol	Badalona	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital Clinico de San Carlos	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Universitari I Politècnic de La Fé	Valencia
Spain	Hospital Clinico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren 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. — View Citation

Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Bärwolf 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Søndergaard 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. — View Citation

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. — View Citation

Thyregod HG, Steinbrüchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrøm T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Søndergaard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cardiovascular death	Cumulative incidence of a combination of all cause Cardiovascular death	30 days post-index procedure
Secondary	Assessment of early safety	Proportion of patients with early safety defined by the Valve Academic Research Consortium-2 (VARC-2) as: All-cause mortality; All stroke (disabling and non-disabling); Life-threatening bleeding; Acute kidney injury-Stage 2 or 3 (including renal replacement therapy); Coronary artery obstruction requiring intervention; Major vascular complication; Valve-related dysfunction requiring repeat procedure	30 days
Secondary	Assessment of time-related valve safety	Proportion of patients with structural valve deterioration as defined by: Requiring repeat procedure (transcatheter or surgical heart valve replacement); Valve-related dysfunction defined by; mean aortic valve gradient =20 mmHg and; no moderate or severe prosthetic valve regurgitation; Prosthetic valve endocarditis; Prosthetic valve thrombosis; Thrombo-embolic events (e.g. stroke); VARC bleeding, unless clearly unrelated to valve therapy	30 days
Secondary	Assesment of NYHA (New York Heart Association ) classification	Assesment of NYHA classification	7 days, 30 days, 12 month
Secondary	Assessment of mean aortic gradient post-implantation	Assessment of mean aortic gradient post-implantation	up to one year
Secondary	Death during the hospitalization of the patient	Proportion of patients with death during the hospitalization designated by the VARC-2 criteria	date of procedure till date of estimated discharge, assessed up to two weeks