Aortic StenosisPRECISANCT03846557

PRospective Evaluation Complementing Investigation With Acurate Neo Device

An observational study of Aortic Stenosis, run by Fundación EPIC at 10 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Stenosis
What is being tested?: Transcatheter Aortic Valve Implantation (TAVI)
Type of treatment: Medical device
How many people: 300 participants
Where: 10 sitesSpain
Study dates: 20 May 2019to 2 Oct 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

≥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.

Who cannot join

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Spain10 sites

Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Universitario de Burgos
Burgos, 09006
Hospital Universitario Virgen de Las Nieves
Granada, 18014
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Clinico de San Carlos
Madrid, 28040
Hospital Universitario de La Paz
Madrid, 28046
Hospital Universitari I Politècnic de La Fé
Valencia, 46026
Hospital Clinico Universitario de Valladolid
Valladolid, 47003

Other trials in Spain

About this study

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

Read the detailed 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.

Conditions: Aortic Stenosis
Being tested: Transcatheter Aortic Valve Implantation (TAVI)
Keywords: TAVI, Valve
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03846557
Study group	Role	What they receive
Treatment		Transcatheter Aortic Valve Implantation (TAVI) Device Receives: Device: Transcatheter Aortic Valve Implantation (TAVI)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 7 days
Cardiovascular death
Cumulative incidence of a combination of all cause Cardiovascular death
Measured: 30 days post-index procedure

Secondary outcomes (5)

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
Measured: 30 days
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
Measured: 30 days
Assesment of NYHA (New York Heart Association ) classification
Assesment of NYHA classification
Measured: 7 days, 30 days, 12 month
Assessment of mean aortic gradient post-implantation
Assessment of mean aortic gradient post-implantation
Measured: up to one year
Death during the hospitalization of the patient
Proportion of patients with death during the hospitalization designated by the VARC-2 criteria
Measured: date of procedure till date of estimated discharge, assessed up to two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 20192 Oct 2021

First posted19 Feb 2019
Study start20 May 2019
Primary completion2 Sep 2021
Study completion2 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Aortic StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03846557
Sponsor's protocol ID: PRECISA -EPIC 11
Acronym: PRECISA
Status last verified: Jan 2022
First submitted: 11 Feb 2019
Last updated: 18 Jun 2025
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 20961243
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.
PubMed 21639811
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.
PubMed 25184874
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.
PubMed 27040324
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.
PubMed 28304219
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.
PubMed 25787196
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.
PubMed 28886619
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.
PubMed 12831818
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.
PubMed 29329825
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.
PubMed 38577931

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRospective Evaluation Complementing Investigation With Acurate Neo Device
ClinicalTrials.gov ID: NCT03846557
Acronym / sponsor ID: PRECISA / PRECISA -EPIC 11
Conditions: Aortic Stenosis
Keywords: TAVI, Valve
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Fundación EPICUniversity, hospital or other
Study start: 20 May 2019 (actual)
Primary completion: 2 Sep 2021 (actual)
Study completion: 2 Oct 2021 (actual)
First posted: 19 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed 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.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Treatment	–	Device: Transcatheter Aortic Valve Implantation (TAVI)Transcatheter Aortic Valve Implantation (TAVI) Device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

≥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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcatheter Aortic Valve Implantation (TAVI)Implantation of the Acurate Neo Transcatheter Heart Valve	Device	Treatment

Primary outcome

Device success of implantation
Time frame: 7 days
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
Cardiovascular death
Time frame: 30 days post-index procedure
Cumulative incidence of a combination of all cause Cardiovascular death

5 secondary outcomes

Assessment of early safety
Time frame: 30 days
Assessment of time-related valve safety
Time frame: 30 days
Assesment of NYHA (New York Heart Association ) classification
Time frame: 7 days, 30 days, 12 month
Assessment of mean aortic gradient post-implantation
Time frame: up to one year
Death during the hospitalization of the patient
Time frame: date of procedure till date of estimated discharge, assessed up to two weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Background: PubMed 20961243Leon 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.
Background: PubMed 21639811Smith 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.
Background: PubMed 25184874Adams 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.
Background: PubMed 27040324Leon 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.
Background: PubMed 28304219Reardon 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.
Background: PubMed 25787196Thyregod 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.
Background: PubMed 28886619Baumgartner 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.
Background: PubMed 12831818Iung 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.
Background: PubMed 29329825Pesarini 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.
Derived from this study: PubMed 38577931Tebar 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.
Individual participant dataSharing planned: No

Related trials for Aortic Stenosis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis, run by Fundación EPIC at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device success of implantation (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03846557, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.