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Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Delta VO2 max and Delta VO2 at anaerobic threshold | Change in CPET parameters after Transcatheter Aortic valve implantation (TAVI): VO2 max, VO2 at anaerobic threshold | CPET performed 2 weeks before TAVI and 4-6 weeks after |
| Clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI | 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). | CPET performed 2 weeks before TAVI and 4-6 weeks after |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical predictors of improvement in quality of life | To identify clinical, echocardiographic and functional pre-TAVI variables that predict improvement in quality of life | 2 weeks before TAVI and 4-6 weeks after |
| pre-TAVI CPET parameters that predict in-hospital complications. |
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Inclusion Criteria:
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
self-representation of gender identity
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Patients 18 years of age or older, with severe, non-critical, aortic stenosis who are scheduled for transfemoral TAVI will participate in the study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Giménez-Milà | Contact | 696762626 | magimene@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Barcelona | Recruiting | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42139369 | Derived | Martinez-Otero S, Gimenez-Mila M, Arguis MJ, Regueiro A, Rodriguez-Arias JJ, Sanz de la Garza M, Berenguel A, Gadella A, Kenneally LF, Martinez-Palli G. Clinical and cardiopulmonary predictors of functional recovery and complications after transcatheter aortic valve implantation: Protocol of a prospective interventional study. PLoS One. 2026 May 15;21(5):e0348568. doi: 10.1371/journal.pone.0348568. eCollection 2026. |
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Correlation between pre-TAVI CPET parameters and in-hospital complications. |
| CPET performed 2 weeks before TAVI and 4-6 weeks after |