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

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

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 161

Contacts and Locations

• Study Contact: Name: Marc Giménez-Milà; Phone Number: 696762626; Email: magimene@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic Barcelona
    • Contact: Marc Giménez-Mila, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Correlation between pre-TAVI CPET parameters and in-hospital complications.	CPET performed 2 weeks before TAVI and 4-6 weeks after

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: TAVI-CPET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No