Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)PERFECTNCT07343674

PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI

An observational study of Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II), run by Portuguese Association of Interventional Cardiology at 12 sites in Portugal.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
How many people: 500 participants
Where: 12 sitesPortugal
Study dates: 14 Jan 2026to Apr 2028
How long will I take part?: 1 Year
Phase: Observational

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: The study population includes patients with severe, symptomatic AS with indication for TAVI, who meet the criteria for use of the Medtronic EvolutTM FX+ System in accordance with IFU and local regulations.

Who may be able to join

Subjects more than 18 years old, able to provide an Informed Consent:
Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause;
Subjects provided written Informed Consent as approved by the Ethics Committee (EC);

Who cannot join

Subjects with pre-existing surgical bioprosthetic aortic valve;
Hepatic insufficiency (Child-Pugh Class B or C);
Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU);
Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system;
Subjects are currently participating in another clinical investigation that may confound the results of this Registry;
Subjects have an expected survival less than one year.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rui C Teles, MD, PhD contact

(+351) 210 433 069

rcteles@outlook.com

Joana D Silva, MD, PhD contact

secretariado.apic@spc.pt

City, postcode or hospital

Sites recruiting now only

12 sites in 1 country

Portugal12 sites, 12 recruiting

Hospitais da Universidade de Coimbra
Coimbra, Coimbra District, 3004-561
Joana D Silva, MD, PhD, joanadelgadosilva@gmail.com
Joana D Silva, MD, PhD
Recruiting
Hospital da Luz Coimbra
Coimbra, Coimbra District, 3020-479
Marco Costa, MD, marcocostacard@sapo.pt
Marco Costa, MD
Not yet recruiting
Hospital do Espírito Santo de Évora
Evora, Évora District, 7000-811
Lino Patrício, MD, PhD, linopatricio@gmail.com
Lino Patrício, MD, PhD
Not yet recruiting
Hospital Dr. Nélio Mendonça
Funchal, Madeira, 9004-514
Bruno Silva, MD, brunofranciscosilva@gmail.com
Bruno Silva, MD
Recruiting
Hospital CUF Tejo
Lisbon, Lisbon District, 1350-352
António Fiarresga, MD, PhD, antonio.fiarresga@jmellosaude.pt
António Fiarresga, MD, PhD
Recruiting
Hospital de Santa Cruz
Lisbon, Lisbon District, 1449-005
João Brito, MD, jdbrito@netcabo.pt
João Brito, MD
Recruiting
Hospital Lusíadas Lisboa
Lisbon, Lisbon District, 1500-458
Eduardo I Oliveira, MD, e.infante.de.oliveira@gmail.com
Eduardo I Oliveira, MD
Not yet recruiting
Hospital da Luz Lisboa
Lisbon, Lisbon District, 1500-650
Pedro Gonçaves, MD, PhD, paraujogoncalves@yahoo.co.uk
Pedro Gonçalves, MD, PhD
Not yet recruiting
Hospital Santa Maria
Lisbon, Lisbon District, 1649-035
Pedro C Ferreira, MD, pcarrilhoferreira@gmail.com
Pedro C Ferreira, MD
Recruiting
Hospital Santa Marta
Lisbon, Lisbon District, 2855-697
Duarte Cacela, MD, dcacela@hotmail.com
Duarte Cacela, MD
Recruiting
Hospital Universitário de São João
Porto, Porto District, 4200-319
Ricardo Lopes, MD, rjlclopes@hotmail.com
Ricardo Lopes, MD
Recruiting
Hospital Eduardo Santos Silva
Vila Nova de Gaia, Vila Nova de Gaia, 4434-502
Pedro Braga, MD, jbraga@ulsge.min-saude.pt
Pedro Braga, MD
Recruiting

Other trials in Portugal

About this study

The main questions it aims to answer are:

Can using a standardized procedure for the impantation of the Medtronic Evolut™ FX+ TAVI System increase safety and efficiency?
What are the short-term (30 days) and long-term (1 year) patient outcomes, including the need for a pacemaker, complications, and valve function?

Participants will undergo TAVI with the Medtronic Evolut™ FX+ TAVI System as part of their routine care.

Be followed during their hospital stay, at 30 days, and at 1 year to check heart health, valve function, and recovery. 500 people at 12 hospitals in Portugal will take part in this registry.

Conditions: Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Keywords: TAVI, Transcatheter Aortic Valve Implantation, Evolut FX+, Aortic Stenosis, Cusp Overlap Technique, Conduction Disorders, Evolut FX+ TAVI System, TAVI System
Medical subject headings: Aortic Valve Stenosis, Arrhythmias, Cardiac

What participants receive

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

Study groups in NCT07343674
Study group	Role	What they receive
Patients with severe aortic stenosis undergoing Medtronic Evolut FX+ TAVI System		Subjects with severe, symptomatic aortic stenosis (AS) with indication for TAVI (Transcatheter Aortic Valve Implant) with the Medtronic Evolut™ FX+ TAVI System - registry of routine practice.

What is being measured

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

VARC-3 technical success
A composite outcome assessed immediately after the TAVI procedure, including: survival, successful vascular access and device deployment/retrieval, correct positioning of a single valve, and freedom from major complications or need for surgery/intervention (excluding pacemaker).
Measured: Immediately after the index procedure

Secondary outcomes (11)

Rate of Permanent Pacemaker Implantation (PPI)
Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances.
Measured: 30 days after procedure
Length of Hospital Stay
Number of days from TAVI procedure to discharge.
Measured: Up to 30 days after procedure
All-Cause Mortality
Death from any cause.
Measured: 30 days and 1 year
Stroke
Any new neurologic deficit classified as a stroke by clinical evaluation.
Measured: 30 days and 1 year
Life-Threatening Bleeding
Severe bleeding events defined by VARC-3 criteria.
Measured: 30 days and 1 year
Acute Kidney Injury
Kidney dysfunction as defined by VARC-3 criteria.
Measured: 30 days and 1 year
Coronary Artery Obstruction
Blockage requiring clinical intervention.
Measured: 30 days and 1 year
Major Vascular Complications
Serious vascular complications as defined by VARC-3 criteria
Measured: 30 days and 1 year
Valve Dysfunction Requiring Reintervention
Prosthetic valve dysfunction that requires repeat procedure.
Measured: 30 days and 1 year
Rehospitalization
Rehospitalization for valve-related symptoms or worsening heart failure.
Measured: 30 days and 1 year
Prosthetic Valve Function
Echocardiographic measures of valve function: left ventricular ejection fraction, peak velocity, mean gradient, effective orifice area, indexed effective orifice area, and prosthetic aortic valve regurgitation.
It is defined as YES if: peak velocity is < 3 m/s AND mean gradient < 20 mmHg AND DVI > 0,25* AND Regurgitation < moderate (this means that LV and index EOA are indirectly in it, no cutt offs are needed)
- DVI is the ratio of the Velocity-Time Integral (VTI) in the Left Ventricular Outflow Tract (LVOT) to the VTI across the stenotic aortic valve. It is measured based on the peak velocity /Grad, Effective orifice area (cm²)
Measured: 30 days and 1 year

Timeline

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

14 Jan 2026Apr 2028

First posted15 Jan 2026
Study start14 Jan 2026
Primary completionNov 2027 (estimated)
Study completionApr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)Studies 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: Cohort
Time perspective: Prospective
Enrolment: 500 participants (estimated)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT07343674
Sponsor's protocol ID: PERFECT Registry
Acronym: PERFECT
Status last verified: Jul 2026
First submitted: 26 Nov 2025
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
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
Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
PubMed 24678937
Popma JJ, Reardon MJ. Transcatheter Aortic-Valve Replacement in Low-Risk Patients. Reply. N Engl J Med. 2019 Aug 15;381(7):685. doi: 10.1056/NEJMc1908500. No abstract available.
PubMed 31412190
Guerreiro C, Ferreira PC, Teles RC, Braga P, Canas da Silva P, Patricio L, Silva JC, Baptista J, de Sousa Almeida M, Gama Ribeiro V, Silva B, Brito J, Infante Oliveira E, Cacela D, Madeira S, Silveira J. Short and long-term clinical impact of transcatheter aortic valve implantation in Portugal according to different access routes: Data from the Portuguese National Registry of TAVI. Rev Port Cardiol (Engl Ed). 2020 Dec;39(12):705-717. doi: 10.1016/j.repc.2020.02.014. Epub 2020 Nov 28. English, Portuguese.
PubMed 33261991
Urena M, Hayek S, Cheema AN, Serra V, Amat-Santos IJ, Nombela-Franco L, Ribeiro HB, Allende R, Paradis JM, Dumont E, Thourani VH, Babaliaros V, Francisco Pascual J, Cortes C, Del Blanco BG, Philippon F, Lerakis S, Rodes-Cabau J. Arrhythmia burden in elderly patients with severe aortic stenosis as determined by continuous electrocardiographic recording: toward a better understanding of arrhythmic events after transcatheter aortic valve replacement. Circulation. 2015 Feb 3;131(5):469-77. doi: 10.1161/CIRCULATIONAHA.114.011929. Epub 2014 Dec 2.
PubMed 25466975
Auffret V, Puri R, Urena M, Chamandi C, Rodriguez-Gabella T, Philippon F, Rodes-Cabau J. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation. 2017 Sep 12;136(11):1049-1069. doi: 10.1161/CIRCULATIONAHA.117.028352.
PubMed 28893961
Pagnesi M, Kim WK, Baggio S, Scotti A, Barbanti M, De Marco F, Adamo M, Eitan A, Estevez-Loureiro R, Conradi L, Toggweiler S, Mylotte D, Veulemans V, Sondergaard L, Wolf A, Giannini F, Maffeo D, Pilgrim T, Montorfano M, Zweiker D, Ferlini M, Kornowski R, Hildick-Smith D, Taramasso M, Abizaid A, Schofer J, Sinning JM, Van Mieghem NM, Wohrle J, Khogali S, Van der Heyden JAS, Wood DA, Ielasi A, MacCarthy P, Brugaletta S, Hamm CW, Costa G, Testa L, Massussi M, Alarcon R, Schafer U, Brunner S, Reimers B, Lunardi M, Zeus T, Vanhaverbeke M, Naber CK, Di Ienno L, Buono A, Windecker S, Schmidt A, Lanzillo G, Vaknin-Assa H, Arunothayaraj S, Saccocci M, Siqueira D, Brinkmann C, Sedaghat A, Ziviello F, Seeger J, Rottbauer W, Brouwer J, Buysschaert I, Jelisejevas J, Bharucha A, Regueiro A, Metra M, Colombo A, Latib A, Mangieri A. Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves. JACC Cardiovasc Interv. 2023 Aug 28;16(16):2004-2017. doi: 10.1016/j.jcin.2023.05.020. Epub 2023 Jul 19.
PubMed 37480891
Szotek M, Druzbicki L, Sabatowski K, Amoroso GR, De Schouwer K, Matusik PT. Transcatheter Aortic Valve Implantation and Cardiac Conduction Abnormalities: Prevalence, Risk Factors and Management. J Clin Med. 2023 Sep 19;12(18):6056. doi: 10.3390/jcm12186056.
PubMed 37762995
Jorgensen TH, De Backer O, Gerds TA, Bieliauskas G, Svendsen JH, Sondergaard L. Mortality and Heart Failure Hospitalization in Patients With Conduction Abnormalities After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Jan 14;12(1):52-61. doi: 10.1016/j.jcin.2018.10.053.
PubMed 30621978
Maier O, Piayda K, Afzal S, Polzin A, Westenfeld R, Jung C, Zeus T, Antoch G, Kelm M, Veulemans V. Computed tomography derived predictors of permanent pacemaker implantation after transcatheter aortic valve replacement: A meta-analysis. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):E897-E907. doi: 10.1002/ccd.29805. Epub 2021 Jun 2.
PubMed 34076343
Abdelshafy M, Elkoumy A, Elzomor H, Abdelghani M, Campbell R, Kennedy C, Kenny Gibson W, Fezzi S, Nolan P, Wagener M, Arsang-Jang S, Mohamed SK, Mostafa M, Shawky I, MacNeill B, McInerney A, Mylotte D, Soliman O. Predictors of Conduction Disturbances Requiring New Permanent Pacemaker Implantation following Transcatheter Aortic Valve Implantation Using the Evolut Series. J Clin Med. 2023 Jul 22;12(14):4835. doi: 10.3390/jcm12144835.
PubMed 37510950
Jung S, Kondruweit M, Marwan M, Achenbach S. Anatomical and Functional Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation. J Am Heart Assoc. 2025 May 20;14(10):e039020. doi: 10.1161/JAHA.124.039020. Epub 2025 May 15.
PubMed 40371597
Jang SJ, Chen YH, Shen TC. Pitfalls in recapture or repositioning of Evolut system using cusp overlap technique. Eur Heart J. 2022 May 1;43(17):1684. doi: 10.1093/eurheartj/ehab824. No abstract available.
PubMed 34864965
Wienemann H, Maier O, Beyer M, Portratz M, Tanaka T, Mauri V, Ernst A, Waldschmidt L, Kuhn E, Bleiziffer S, Wilde N, Schaefer A, Zeus T, Baldus S, Zimmer S, Veulemans V, Rudolph TK, Adam M. Cusp overlap versus standard three-cusp technique for self-expanding Evolut transcatheter aortic valves. EuroIntervention. 2023 Jun 5;19(2):e176-e187. doi: 10.4244/EIJ-D-22-01030.
PubMed 37013922
Moura AR, Rodrigues JA, Braga P, Melica B, Santos L, Pires-Morais G, Sampaio F, Fontes-Carvalho R. Impact of the use of cusp-overlap projection on the incidence of permanent pacemaker implantation post-transcatheter aortic valve implantation with self-expanding valves. Rev Port Cardiol. 2023 Sep;42(9):759-769. doi: 10.1016/j.repc.2022.10.011. Epub 2023 Mar 21. English, Portuguese.
PubMed 36948457