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NCT Number: NCT06833762

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

Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinic Barcelona

Barcelona, Spain

Location status: Recruiting

Location contact

Marc Giménez-Mila, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Delta VO2 max and Delta VO2 at anaerobic threshold

    Time frame: 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

  2. Clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI

    Time frame: 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 outcomes

  1. Clinical predictors of improvement in quality of life

    Time frame: 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

  2. pre-TAVI CPET parameters that predict in-hospital complications.

    Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after

    Correlation between pre-TAVI CPET parameters and in-hospital complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Giménez-Milà

CONTACT

[email protected]

696762626

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Determining Clinical and Cardiopulmonary Exercise Testing Parameters That Predict Improvement in Functional Capacity and Complications After Transcatheter Aortic Valve Implantation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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