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Heart wave tech may predict TAVR success

NCT ID NCT07509554

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

60 to 90 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Istanbul Mehmet Akif Ersoy Educational and Training Hospital

    Istanbul, Turkey (Türkiye)

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