Which clinical and exercise-test measures predict better fitness after transcatheter aortic valve implantation (TAVI)
Official title: Determining Clinical and Cardiopulmonary Exercise Testing Parameters That Predict Improvement in Functional Capacity and Complications After Transcatheter Aortic Valve Implantation
Run by Hospital Clinic of Barcelona · NCT06833762 · Data updated 2026-11-12
This study tries to see if clinical measures and cardiopulmonary exercise testing can predict which adults with severe aortic stenosis will have improved physical fitness after transfemoral TAVI.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 161 (estimated) |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | June 2027 |
| Study ends | July 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT06833762 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with severe aortic stenosis approved for transfemoral TAVI who can consent and safely perform CPET are eligible.
✕Probably not a fit
Patients with very severe aortic stenosis (valve area ≤0.6 cm², mean gradient ≥60 mmHg or Vmax >5 m/s), prior syncope, exercise-induced arrhythmias, known dynamic LVOT obstruction, unresolved coronary disease needing PCI, inability to perform exercise testing, non-elective procedures, or valve-in-valve procedures are excluded and unlikely to benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort study enrolling 161 adults with severe aortic stenosis scheduled for transfemoral TAVI to characterize mid-term changes in exercise tolerance and identify predictors of improvement. Participants undergo a standardized incremental cardiopulmonary exercise test (CPET) and clinical evaluation within two weeks before TAVI and again 4–6 weeks after the procedure. A positive functional response is predefined as an increase in VO2 peak >2.5 ml/kg/min or >10% from baseline. The study will analyze clinical measures (symptoms, frailty, quality of life) and CPET-derived parameters to determine which factors are associated with meaningful post-TAVI improvement.
Why it matters
Potential benefit: If successful, the findings could help clinicians predict who is likely to experience meaningful gains in exercise capacity after TAVI and guide patient counseling and selection.
How similar studies have gone: Previous studies of functional outcomes after TAVI have produced mixed results, and using CPET to predict functional benefit is relatively novel with limited prior evidence of consistent success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospital Clinic Barcelona
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Marc Giménez-Milà
- Email: magimene@clinic.cat
- Phone: 696762626
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.