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RecruitingNCT06833762Updated Sep 2, 2026

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

An observational study in Aortic Stenosis Disease, sponsored by Hospital Clinic of Barcelona. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Hospital Clinic of Barcelona · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
161
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 82 studies in Aortic Valve Stenosis with a site in Spain — 24 open to participants now, 31 under way, 1 of them phase 3. Aortic Valve Stenosis · Spain.

Planned enrollment
39th of 46
161 · median 373
Started
2025
with 4 others
Observational
46 of 82
9 open now
Primary completion
2027-06
later than 17 of 30 live
Registered
75th of 82
by date
Lead sponsor
4 of 82
Hospital Clinic of Barcelona

Among the 82 studies in Aortic Valve Stenosis with a site in Spain, this one is the 39th largest by planned enrollment of the 46 observational ones that give a count, is one of 5 that started in 2025, is one of 46 observational ones, reaches primary completion later than 17 of the 30 other live ones, and was the 75th registered.

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 161 is below the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Open to participants now

24 of the 82 studies in Aortic Valve Stenosis with a site in Spain are open now.

All 24 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 82 studies in Aortic Valve Stenosis with a site in Spain, or all of them as a file.
02

Study summary

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

Read the 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.

03

Conditions studied

  • Aortic Stenosis Disease
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
161 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Martinez-Otero S, Gimenez-Mila M, Arguis MJ, Regueiro A, Rodriguez-Arias JJ, Sanz de la Garza M, Berenguel A, Gadella A, Kenneally LF, Martinez-Palli G. Clinical and cardiopulmonary predictors of functional recovery and complications after transcatheter aortic valve implantation: Protocol of a prospective interventional study. PLoS One. 2026 May 15;21(5):e0348568. doi: 10.1371/journal.pone.0348568. eCollection 2026. PubMed 42139369 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 29 months is below that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2025
First posted
Feb 19, 2025
StartActual
Jan 1, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Jul 2027
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06833762
Responsible party
Sponsor
First posted
Feb 19, 2025
Start date
Jan 1, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Marc Giménez-Milà
Contact
magimene@clinic.cat
696762626

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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