Post-Market Clinical Follow Up Study With Navitor Valve

Официальное название

VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)

Обзор

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Подробное описание

The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

Вмешательства

• Устройство Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
  Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System

Первичные конечные точки

• All-cause mortality at 30 days post-TAVI procedure [Срок оценки: 30 days post index procedure]
• Moderate or greater paravalvular leak at 30 days post-TAVI procedure [Срок оценки: 30 days post index procedure]

Критерии участия

Критерии включения

• Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.
• The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the IRB (Investigational Review Board)/EC (Ethics Committee) of the respective clinical site.
• The patient and the treating physician agree that the subject will return for all required post procedure follow up visits.

Критерии исключения

• Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU)
• Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
• In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
• Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
• Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
• Currently participating in an investigational drug or device study that may confound the results of this study
• Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 11 центров

• Herz- u. Gefäßzentrum Bad Bevensen — Bad Bevensen
• Deutsches Herzzentrum der Charité — Berlin
• Medizinische Einrichtungen der Universität zu Köln — Cologne
• St Johannes Hospital Dortmund — Dortmund
• Kliniken der Friedrich-Alexander-Universitat — Erlangen
• Klinikum der Johann Wolfgang Goethe-Universität Frankfurt — Frankfurt
• UKE Hamburg — Hamburg
• Universitätsklinikum Schleswig-Holstein - Campus Kiel — Kiel
• … и ещё 3 центра

Италия · 8 центров

• Az. Osp. Spedali Civili di Brescia — Brescia
• Casa di Cura Pineta Grande — Castel Volturno
• Centro Cardiologico Monzino — Milan
• Ospedale San Raffaele - Cardiac — Milan
• IRCCS ISMETT - Palermo — Palermo
• Policlinico Universitario A. Gemelli — Roma
• Policlinico San Donato — San Donato Milanese
• Ospedale Umberto I di Torino — Torino

Испания · 8 центров

• Hospital Universitario de Badajoz — Badajoz
• Hospital Clinic de Barcelona — Barcelona
• Hospital de la Santa Creu I Sant Pau — Barcelona
• Hospital General Juan Ramon Jimenez — Huelva
• Hospital de Gran Canaria Doctor Negrín — Las Palmas
• Hospital Universitario Puerta de Hierro — Majadahonda
• HCU Virgen de la Victoria — Málaga
• Consorcio Hospital General Universitario de Valencia — Valencia

Франция · 6 центров

• Institute Cardio. Paris-Sud - Institut Jacques Cartier — Massy
• Clinique du Millénaire — Montpellier
• Mutualiste Montsouris — Paris
• CHRU Hopital de Pontchaillou — Rennes
• CHU Pointchaillou Rennes — Rennes
• Clinique Pasteur Toulouse — Toulouse

Великобритания · 6 центров

• Kings College Hospital — London
• St. Thomas Hospital — London
• James Cook University Hospital — Middlesbrough
• Royal Stoke University Hospital — Stoke-on-Trent
• Royal Stoke University Hospital — Stoke-on-Trent
• New Cross Hospital — Wolverhampton

Австралия · 3 центра

• Royal Adelaide Hospital — Adelaide
• Royal Hobart Hospital — Hobart
• The Alfred Hospital — Melbourne

Нидерланды · 3 центра

• Onze Lieve Vrouw Gasthuis — Amsterdam
• Leiden University Medical Center — Leiden
• UMC Utrecht — Utrecht

Португалия · 2 центра

• ULS de Lisboa Ocidental — Carnaxide
• ULS de São José — Lisbon

Израиль · 1 центр

• Sheba Medical Center — Tel Litwinsky

Швеция · 1 центр

• Sahlgrenska University Hospital - Gothenburg — Gothenburg

Швейцария · 1 центр

• KS St. Gallen / USZ — Sankt Gallen

Идентификаторы

NCT: NCT06008080 · ABT-CIP-10476

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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