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

Обзор

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. 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.

Первичные конечные точки

• VARC-3 technical success [Срок оценки: Immediately after the index procedure]

Вторичные конечные точки (11)

• Rate of Permanent Pacemaker Implantation (PPI) [Срок оценки: 30 days after procedure]
• Length of Hospital Stay [Срок оценки: Up to 30 days after procedure]
• All-Cause Mortality [Срок оценки: 30 days and 1 year]
• Stroke [Срок оценки: 30 days and 1 year]
• Life-Threatening Bleeding [Срок оценки: 30 days and 1 year]
• Acute Kidney Injury [Срок оценки: 30 days and 1 year]
• Coronary Artery Obstruction [Срок оценки: 30 days and 1 year]
• Major Vascular Complications [Срок оценки: 30 days and 1 year]
• Valve Dysfunction Requiring Reintervention [Срок оценки: 30 days and 1 year]
• Rehospitalization [Срок оценки: 30 days and 1 year]
• Prosthetic Valve Function [Срок оценки: 30 days and 1 year]

Критерии участия

Критерии включения

• 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);

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Португалия · 12 центров

• Hospitais da Universidade de Coimbra — Coimbra
• Hospital da Luz Coimbra — Coimbra
• Hospital CUF Tejo — Lisbon
• Hospital de Santa Cruz — Lisbon
• Hospital Lusíadas Lisboa — Lisbon
• Hospital da Luz Lisboa — Lisbon
• Hospital Santa Maria — Lisbon
• Hospital Santa Marta — Lisbon
• … и ещё 4 центра

Публикации

• 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):1 PMID 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 PMID 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. PMID 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 Cardio PMID 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 e PMID 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. PMID 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, MacCa PMID 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. PMID 37762995

Идентификаторы

NCT: NCT07343674 · PERFECT Registry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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