Which clinical and exercise-test measures predict better fitness after transcatheter aortic valve implantation (TAVI)
Determining Clinical and Cardiopulmonary Exercise Testing Parameters That Predict Improvement in Functional Capacity and Complications After Transcatheter Aortic Valve Implantation
Hospital Clinic of Barcelona · NCT06833762
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 |
|---|---|
| Enrollment | 161 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06833762 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with severe aortic stenosis approved for transfemoral TAVI who can consent and safely perform CPET are eligible.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Barcelona
- Hospital Clinic Barcelona — Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Marc Giménez-Milà
- Email: magimene@clinic.cat
- Phone: 696762626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Stenosis Disease