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Search / Trial NCT06833762

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

Launched by HOSPITAL CLINIC OF BARCELONA · Feb 13, 2025

Trial Information

Current as of July 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to understand how certain health factors can help predict whether patients will see improvements in their physical abilities after undergoing a procedure called Transcatheter Aortic Valve Implantation (TAVI). TAVI is used to treat severe aortic stenosis, a condition where the heart's aortic valve narrows and makes it harder for blood to flow. By studying various clinical and exercise testing parameters, researchers hope to identify which patients are most likely to benefit from the procedure.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with severe aortic stenosis, with a focus on those who will receive TAVI through the femoral artery. However, individuals with very severe aortic stenosis or certain heart conditions, as well as those who cannot participate in exercise tests or require an emergency procedure, will not be included. If you join this trial, you can expect to undergo some tests and evaluations to help the researchers gather information that may improve care for future patients undergoing TAVI.

Gender

ALL

Eligibility 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

About Hospital Clinic Of Barcelona

The Hospital Clinic of Barcelona is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, the hospital integrates cutting-edge medical practices with rigorous scientific inquiry to enhance patient outcomes. As a prominent sponsor of clinical trials, the Hospital Clinic of Barcelona is dedicated to exploring new therapies and treatment modalities across various medical fields, fostering a culture of excellence in clinical research that ultimately aims to improve the quality of care for patients locally and globally.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported