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

Not yet recruiting

• Conditions: Aortic Stenosis Disease

• Registration Number: NCT06833762
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Study Start: 2025-03
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Clinical predictors of improvement in quality of life	2 weeks before TAVI and 4-6 weeks after	To identify clinical, echocardiographic and functional pre-TAVI variables that predict improvement in quality of life
pre-TAVI CPET parameters that predict in-hospital complications.	CPET performed 2 weeks before TAVI and 4-6 weeks after	Correlation between pre-TAVI CPET parameters and in-hospital complications.