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NCT07509554

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

Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital

View on ClinicalTrials.gov

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.

Official title: Investigation of the Relationship Between Changes in Modern Wave-Based Hemodynamic Metrics and Procedural Success or Clinical Improvement in Patients With Severe Aortic Stenosis Following Transcatheter Aortic Valve Replacement (TAVR)

Key Details

Gender

All

Age Range

60 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-03-30

Completion Date

2029-08

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Aortic Stenosis

Interventions

PROCEDURE

Transcatheter aortic valve replacement (TAVR / TAVI)

TAVI is performed as per standard procedural guidelines

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.

Locations (1)

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Istanbul, Turkey (Türkiye)