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

NCT06833762 | Recruiting

• 1 other identifier: TAVI-CPET
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Stenosis Disease

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Clinical predictors of improvement in quality of life

  2 weeks before TAVI and 4-6 weeks after

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

  CPET performed 2 weeks before TAVI and 4-6 weeks after

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 18 years of age or older, with severe, non-critical, aortic stenosis who are scheduled for transfemoral TAVI will participate in the study

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Spain

RECRUITING

Central Study Contacts

Marc Giménez-Milà

CONTACT

696762626; magimene@clinic.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2024-10

Locations

ES (1)