Predicting Functional Improvement and Complications After Transcatheter Aortic Valve Implantation Using Clinical and Exercise Testing Parameters
Led by Hospital Clinic of Barcelona · Updated on 2026-06-22
161
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research focuses on patients with severe aortic stenosis who are scheduled to undergo Transcatheter Aortic Valve Implantation TAVI, a less invasive alternative to surgical valve replacement. The study aims to understand how TAVI affects patients exercise capacity and to identify clinical and cardiopulmonary exercise testing CPET parameters that predict improvement in functional capacity after the procedure. Researchers will explore both clinical factors like symptoms and quality of life, as well as functional factors from CPET that influence recovery.
Participants will be assessed using an incremental CPET performed on a cycle ergometer, supervised by medical professionals. Testing will occur twice once within two weeks before the TAVI procedure and again 4 to 6 weeks afterward. The study will include 161 patients across three expert centers who meet the criteria for transfemoral TAVI, and it will evaluate both the exercise tolerance response and potential complications related to the procedure.
Throughout the study, participants will undergo clinical and functional evaluations before and after TAVI, including detailed CPET assessments to measure changes in VO2 max and anaerobic threshold. Researchers will also monitor quality of life improvements and in-hospital complications. The total participation duration spans from the pre-TAVI assessment through the post-TAVI follow-up at 4 to 6 weeks, during which various clinical and functional outcomes will be measured and analyzed.
CONDITIONS
Brief Title
Clinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI
Research Team
M
Marc Giménez-Milà
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Physical limitation preventing performance of exercise test
Undergoing non-elective procedure
Undergoing valve-in-valve procedure
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Pre-TAVI Assessment
Duration - Up to 2 weeks
Participants undergo clinical evaluation and supervised cardiopulmonary exercise testing (CPET) within 2 weeks before TAVI.
1 visit
TAVI Procedure
Duration - 1 day
Participants receive the Transcatheter Aortic Valve Implantation procedure.
1 visit
Post-TAVI Follow-up
Duration - 4 to 6 weeks
Participants return for clinical evaluation and CPET 4 to 6 weeks after the TAVI procedure to assess functional improvement.
1 visit
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Clinical and cardiopulmonary predictors of functional recovery and complications after transcatheter aortic valve implantation: Protocol of a prospective interventional study.
Samira Martínez-Otero, Marc Giménez-Milà, María José Arguis...