Not Yet RecruitingNot Applicable

PRessure-based Evaluation of Disease Improvement in the Course of TAVI

Turkey (Türkiye)100 participantsStarted 2026-03-30

Plain-language summary

The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90) with severe Aortic Stenosis who are undergoing Transcatheter Aortic Valve Replacement (TAVR/TAVI). The main questions it aims to answer are: Do changes in heart pressure wave patterns immediately after the new valve is implanted relate to improvements in a patient's quality of life and heart health over the following year? Can these advanced wave measurements better predict major heart complications (MACE) at 30 days, 180 days and 1 year compared to standard clinical tests? Participants will: Undergo a standard TAVR (TAVI) procedure as part of their regular medical care to replace a narrowed heart valve. Have their aortic pressure waves recorded through a catheter during the routine procedure (this happens during the surgery and does not require any additional incisions or invasive steps). Complete quality-of-life surveys (EQ-5D-5L) and clinical assessments before the procedure. Be followed up via telephone calls or electronic health records at 30 days, 180 days and 12 months after the procedure to check on their recovery and overall health status.

Who can participate

Age range60 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 finalize…

What they're measuring

EQ-5D-5L

Timeframe: baseline at admission, at 1 month, 6 months and 12 months follow up

MACE

Timeframe: at 1 month, 6 months and 12 months follow up

WIA

Timeframe: immediately before and after implantation of prosthetic valve (intraprocedural)

REPA

Timeframe: Immediately before and after implantation of prosthetic valve (intraprocedural)

Trial details

NCT IDNCT07509554

SponsorIstanbul Mehmet Akif Ersoy Educational and Training Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2028-07-30

Contact for this trial

Serkan Aslan, Ass. Prof MD

+90(212) 692 20 00 drserkanaslan@gmail.com

View on ClinicalTrials.gov More Aortic Stenosis trials