Heart wave tech may predict TAVR success
NCT ID NCT07509554
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether advanced heart pressure wave analysis can predict how well patients recover after a TAVR procedure for severe aortic stenosis. Researchers will measure pressure waves during the procedure and track quality of life and heart complications over one year in 100 adults aged 60-90. The goal is to see if these wave measurements are better than standard tests at predicting success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors better predict which patients will benefit most from TAVR and improve long-term outcomes.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find a clear link between wave measurements and recovery, limiting its impact.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Consecutive patients with inclusion criteria who are clinical candidates for TAVI based on multidisciplinary heart team evaluation.
- Ages
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60 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 60-90 years. Confirmed diagnosis of severe Aortic Stenosis (AS) and a confirmed guideline-based indication for Transcatheter Aortic Valve Implantation (TAVI) by a multidisciplinary Heart Team, in accordance with the latest ESC/EACTS guidelines. (In the presence of Vmax ≥ 4.0 m/s, Mean Gradient ≥ 40 mmHg, or AVA ≤ 1.0 cm²; applicable primarily to all symptomatic patients, adopting a proactive approach regarding age limits and risk profiles. Guidelines recommend TAVI as the first-line therapy \[Class I\] for all patients aged 70 and older with anatomical suitability and a tricuspid valve structure, regardless of surgical risk. For patients under 70, TAVI is recommended when surgical risk is high or surgery is deemed unsuitable. In asymptomatic individuals, a decline in left ventricular ejection fraction \[LVEF\] below 55% \[not attributable to other causes\] constitutes a Class I indication for intervention. Early intervention \[Class IIa\] is considered for patients with preserved EF but high-risk markers such as very severe stenosis \[Vmax \> 5.0 m/s\], rapid progression \[increase \> 0.3 m/s/year\], significant NT-proBNP elevation \[\> 3 times the upper limit of normal\], or severe pulmonary hypertension. In cases of low-flow, low-gradient \[LFLG\] AS, the indication for TAVI arises if true-severe stenosis is confirmed via dobutamine stress echocardiography or CT calcium scoring \[Male ≥ 2000, Female ≥ 1200\]. All treatment decisions are finalized by a multidisciplinary Heart Team assessing anatomy, frailty, and patient preferences.) Written informed consent. Exclusion Criteria: * Active infection, uncontrolled systemic disease, active malignancy, or life expectancy \< 1 month. Pregnant or lactating patients. Pressure tracings with significant artifacts hindering analysis or uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response). Any other condition deemed clinically unsuitable by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Istanbul, Turkey (Türkiye)
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new heart valve offer a safer fix for aortic stenosis?
- Can Open-Heart surgery outperform a Tube-Based valve fix?
- Can a new heart valve restore quality of life?
- Does replacing a heart valve clear fluid from the lungs?
- AI ultrasound could unmask silent heart disease in seniors