Clinical trial NCT06833762: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Stenosis Disease
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older, with severe, non-critical, aortic stenosis who are scheduled for transfemoral TAVI will participate in the study

Brief summary: 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.

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

Primary outcomes:
measure: Delta VO2 max and Delta VO2 at anaerobic threshold
timeFrame: CPET performed 2 weeks before TAVI and 4-6 weeks after
measure: Clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI
timeFrame: CPET performed 2 weeks before TAVI and 4-6 weeks after
Secondary outcomes:
measure: Clinical predictors of improvement in quality of life
timeFrame: 2 weeks before TAVI and 4-6 weeks after
measure: pre-TAVI CPET parameters that predict in-hospital complications.
timeFrame: CPET performed 2 weeks before TAVI and 4-6 weeks after
Other outcomes:
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