RecruitingNot Applicable

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

Spain161 participantsStarted 2025-01-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delta VO2 max and Delta VO2 at anaerobic threshold

Timeframe: 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

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

Trial details

NCT IDNCT06833762

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Marc Giménez-Milà

696762626 magimene@clinic.cat

View on ClinicalTrials.gov More Aortic Stenosis Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.