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

Official title

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

Overview

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

Detailed description

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.

Primary outcome measures

• Delta VO2 max and Delta VO2 at anaerobic threshold [Time frame: 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 [Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after]

Secondary outcome measures (2)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 1 center

• Hospital Clinic Barcelona — Barcelona

Publications

• 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

Identifiers

NCT: NCT06833762 · TAVI-CPET

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗