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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All those patients ≥ 18 years of age with severe aortic stenosis approved for transfemoral TAVI.

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

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

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).

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

Secondary outcomes

1

Clinical predictors of improvement in quality of life

To identify clinical, echocardiographic and functional pre-TAVI variables that predict improvement in quality of life

Time frame
2 weeks before TAVI and 4-6 weeks after
2

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

Correlation between pre-TAVI CPET parameters and in-hospital complications.

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

Other outcomes

Sponsors and contacts

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