Aortic Stenosis DiseaseNCT06833762
Clinical and CPET Parameters That Predict Improvement in Functional Capacity After TAVI
An observational study of Aortic Stenosis Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis Disease
- How many people
- 161 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Inability to consent
- Physical limitation to perform an exercise test
- Non-elective procedure
- Valve-in-valve procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic Barcelona
Barcelona
Marc Giménez-Mila, MD
About this study
Official title: 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
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.
- Conditions
- Aortic Stenosis Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: CPET performed 2 weeks before TAVI and 4-6 weeks after
Secondary outcomes (2)
Clinical predictors of improvement in quality of life
To identify clinical, echocardiographic and functional pre-TAVI variables that predict improvement in quality of life
Measured: 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.
Measured: CPET performed 2 weeks before TAVI and 4-6 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833762
- Sponsor's protocol ID
- TAVI-CPET
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Clinical and Cardiopulmonary Exercise Testing Parameters That Predict Improvement in Functional Capacity and Complications After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT06833762
- Acronym / sponsor ID
- TAVI-CPET
- Conditions
- Aortic Stenosis Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determining Clinical and Cardiopulmonary exercise testing Parameters that may predict Improvement in Capacity After Transcatheter Aortic Valve Implantation
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delta VO2 max and Delta VO2 at anaerobic threshold
Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after
Change in CPET parameters after Transcatheter Aortic valve implantation (TAVI): VO2 max, VO2 at anaerobic threshold
Clinical and functional pre-TAVI factors that predict improvement in functional capacity after TAVI
Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after
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).
2 secondary outcomes
Clinical predictors of improvement in quality of life
Time frame: 2 weeks before TAVI and 4-6 weeks after
pre-TAVI CPET parameters that predict in-hospital complications.
Time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 42139369Martinez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis Disease, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Giménez-Milà (696762626, magimene@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta VO2 max and Delta VO2 at anaerobic threshold (time frame: CPET performed 2 weeks before TAVI and 4-6 weeks after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06833762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.