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

NCT06833762 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital Clinic of Barcelona

Phase

Observational

Started

2025-01-01

Last updated

2026-09-02

Condition(s) studied

Aortic Stenosis Disease

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Delta VO2 max and Delta VO2 at anaerobic threshold — CPET performed 2 weeks before TAVI and 4-6 weeks after
Change in CPET parameters after Transcatheter Aortic valve implantation (TAVI): VO2 max, VO2 at anaerobic threshold
Clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI — CPET performed 2 weeks before TAVI and 4-6 weeks after
To identify clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI (i.e., VO2 max increase \> 2.5 ml/kg/min or \>10% increase in VO2 max). ml/kg/min or \>10% increase in VO2 max).

Trial sites (1)

Facility	City	Region	Status
Hospital Clinic Barcelona	Barcelona	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833762 on ClinicalTrials.gov ↗ ← All trials in Spain