Clinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI

Официальное название

Determining Clinical and Cardiopulmonary Exercise Testing Parameters That Predict Improvement in Functional Capacity and Complications After Transcatheter Aortic Valve Implantation

Обзор

Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation

Подробное описание

Transcatheter Aortic Valve Implantation (TAVI) has emerged as a less invasive alternative to surgical aortic valve replacement, especially for high-risk patients. However, existing research on functional outcomes after TAVI has yielded mixed results. To our knowledge, the potential functional benefit of TAVI has not been well explored using cardiopulmonary exercise testing (CPET). The present study aims to 1) characterize the mid-term exercise tolerance response to TAVI, and 2) determine the clinical (symptoms, frailty, quality of life, etc.) and functional factors (parameters derived from CPET) that determine the magnitude of this response. A positive functional response to TAVI will be considered as an increase in VO2 max \> 2.5ml/kg/min or \>10% of its baseline value one month post-TAVI. The exercise test will be conducted by a physiotherapist and supervised by a physician using a standard incremental cardiopulmonary exercise testing on cycle ergometer (Ergoline 900, Ergoline, Bitz, Germany (CE-0123) and Ergocard Professional, Medisoft, Sorinnes, Belgium (CE-1434)). To this end, 161 patients with severe aortic stenosis scheduled for TAVI will be included in 3 expert centres. They will be evaluated clinically and functionally (incremental CPET) in the 2 weeks prior to the procedure and 4-6 weeks after.

Первичные конечные точки

• Delta VO2 max and Delta VO2 at anaerobic threshold [Срок оценки: CPET performed 2 weeks before TAVI and 4-6 weeks after]
• Clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI [Срок оценки: CPET performed 2 weeks before TAVI and 4-6 weeks after]

Вторичные конечные точки (2)

• Clinical predictors of improvement in quality of life [Срок оценки: 2 weeks before TAVI and 4-6 weeks after]
• pre-TAVI CPET parameters that predict in-hospital complications. [Срок оценки: CPET performed 2 weeks before TAVI and 4-6 weeks after]

Критерии участия

Критерии включения

• All those patients ≥ 18 years of age with severe aortic stenosis approved for transfemoral TAVI.

Both sexes, male and female will be included in the study.

Критерии исключения

Very severe aortic stenosis, defined as a valve area of ≤0.6 cm2

, mean gradient ≥60 mmHg or Vmax >5 m/s

• Previous syncope
• Proven exercise-induced arrhythmias
• Previously known dynamic left ventricular outflow tract (LVOT) obstruction, defined as LVOT gradient of ≥ 30 mmHg by echocardiography
• Concomitant coronary artery disease pending percutaneous coronary intervention
• Inability to consent
• Physical limitation to perform an exercise test
• Non-elective procedure
• Valve-in-valve procedure

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Hospital Clinic Barcelona — Barcelona

Публикации

• Martinez-Otero S, Gimenez-Mila M, Arguis MJ, Regueiro A, Rodriguez-Arias JJ, Sanz de la Garza M, Berenguel A, Gadella A, Kenneally LF, Martinez-Palli G. Clinical and cardiopulmonary predictors of functional recovery and complications after transcatheter aortic valve implantation: Protocol of a prospective interventional study. PLoS One. 2026 May 15;21(5):e0348568. doi: 10.1371/journal.pone.0348568 PMID 42139369

Идентификаторы

NCT: NCT06833762 · TAVI-CPET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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