Aortic StenosisPREDIC-TAVINCT07509554
PRessure-based Evaluation of Disease Improvement in the Course of TAVI
An observational study of Aortic Stenosis, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2026to Aug 2029
- How long will I take part?
- 1 Year
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with inclusion criteria who are clinical candidates for TAVI based on multidisciplinary heart team evaluation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Istanbul
Serkan Aslan, Ass Prof MD
Ahmet Tas, MD PhD
About this study
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)
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:
Read more
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.
Read the detailed description
Background and Rationale:
Severe Aortic Stenosis (AS) is characterized by the progressive calcification and narrowing of the aortic valve leaflets, leading to a significant mechanical obstruction in the Left Ventricular Outflow Tract (LVOT). While Transcatheter Aortic Valve Replacement (TAVR) has become the gold standard for high-risk and increasingly intermediate-to-low-risk patients, the clinical response remains heterogeneous. Current procedural success is primarily evaluated using steady-flow metrics such as Mean Pressure Gradient (MG) and Aortic Valve Area (AVA). However, the total workload on the Left Ventricle (LV) is not merely a function of valvular resistance but also involves pulsatile components including arterial compliance, wave reflections, and valvulo-arterial impedance. In many TAVR candidates, concomitant systemic arterial stiffness and reduced vascular compliance complicate the hemodynamic profile, making traditional gradients insufficient to fully characterize the true obstructive load and ventricular performance, e.g. in certain disease endotypes subgroups "paradoxical" low-flow, low-gradient (LFLG) phenotypes.
The PREDIC-TAVI study utilizes state-of-the-art wave mechanics to provide a granular assessment of the cardiovascular system's response to TAVR:
- Wave Intensity Analysis (WIA): By analyzing simultaneous changes in pressure and flow (or flow-surrogates), WIA identifies the energy flux of forward-traveling waves (Forward Compression Waves [FCW] generated by LV ejection and Forward Expansion Waves [FEW] during relaxation) and backward-traveling waves (Backward Compression Waves [BCW] reflected from the systemic tree and the stenotic valve).
- Reservoir-Excess Pressure Analysis (REPA): This method decomposes the measured aortic pressure waveform into a reservoir pressure (Pr), reflecting the global arterial storage and compliance dynamics, and an excess pressure (Pxs), representing the dynamic, wave-related component of the pulse. Parameters such as P-infinity (Pinf) serve as proxies for microcirculatory closing pressures.
Study Design and Procedural Methodology: This is a prospective, single-center, observational cohort study. Consecutive patients (aged 60-90 years) with a multidisciplinary "Heart Team" diagnosis of severe AS and a clinical indication for TAVR will be enrolled. The study employs a high-fidelity "pressure-only" approach for hemodynamic analysis. During the routine TAVR procedure, proximal aortic pressure waveforms will be recorded via fluid-filled catheters at a minimum sampling rate of 100 Hz. Recordings will be captured at two specific time points:
- Baseline (Pre-Implantation): Immediately prior to valve deployment under stable hemodynamic conditions.
- Post-Implantation: Following valve deployment and stabilization. Data acquisition occurs within the standard clinical workflow, requiring no additional invasive maneuvers. Waveforms are analyzed offline using standardized signal-processing algorithms (Savitzky-Golay filtering, beat segmentation, and diastolic exponential fitting) to derive delta-WIA and delta-REPA metrics.
Longitudinal Follow-up and Clinical Endpoints: The study aims to correlate acute intra-procedural hemodynamic changes with multidimensional clinical outcomes at three distinct follow-up intervals:
- 1-Month Follow-up (30 ± 5 days):
- 6-Month Follow-up (180 ± 14 days):
- 12-Month Follow-up (1 Year ± 3 weeks):
Primary Outcome Measures:
- Clinical Improvement: Assessed via the change in health-related quality of life using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index scores and Visual Analog Scale (VAS).
- Major Adverse Cardiovascular Events (MACE): A composite of all-cause mortality, stroke (major/minor), myocardial infarction, and unplanned hospitalizations due to heart failure or valve dysfunction, classified according to Valve Academic Research Consortium 3 (VARC-3) criteria. All cause mortality and any ED admissions are separately assessed.
Statistical Analysis Plan: The relationship between hemodynamic deltas and clinical outcomes will be analyzed using Pearson/Spearman correlations and linear regression. To account for the longitudinal follow-up and baseline clinical covariates (e.g., age, gender, comorbidities, and baseline LVEF), Generalized Linear Mixed Models (GLMM) will be utilized. Receiver Operating Characteristic (ROC) curves and Area Under the Curve (AUC) values will be calculated to determine the predictive power of wave-based metrics for 1-year MACE. OR/HR will be calculated for endpoints.
Sample Size Rationale: Based on current literature, TAVR is expected to significantly increase FCW energy and Pxs. To detect a moderate correlation (r=0.35) between these changes and the EQ-5D-5L index with 80% power and 5% alpha, a minimum of 62 patients is required. To ensure robust 1-year MACE prediction (assuming a 28% event rate in the TAVR population per SWEDEHEART registry data) and to account for technical or follow-up attrition, a target enrollment of at least 100 consecutive patients is established.
Scientific Contribution: The PREDIC-TAVI-IMAEH study seeks to define a new "physiological success" signature for TAVR. By moving beyond static gradients, this research aims to improve the diagnostic and prognostic algorithms for severe AS, providing clinicians with sensitive markers to optimize valve deployment and better anticipate the recovery trajectory of complex cardiovascular patients.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Keywords
- TAVI, TAVR, AORTIC STENOSIS, wave intensity analysis, reservoir excess pressure analysis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacement (TAVR / TAVI)Procedure or surgery
TAVI is performed as per standard procedural guidelines
| Study group | Role | What they receive |
|---|---|---|
| TAVI | Patient with severe aortic stenosis who are clinical candidates for TAVI based on multidisciplinary heart team evaluation. Receives: Procedure: Transcatheter aortic valve replacement (TAVR / TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-5L
The 5-level EQ-5D version (EQ-5D-5L) measures health related quality of life
Measured: baseline at admission, at 1 month, 6 months and 12 months follow up
MACE
MACE (defined by VARC-3) will be monitored via electronic health records and telephone-visits.
Measured: at 1 month, 6 months and 12 months follow up
WIA
Wave Intensity Analysis (WIA): By analyzing simultaneous changes in pressure and flow (or flow-surrogates), WIA identifies the energy flux of forward and backward-traveling waves with their temporal and amplitude features.
Measured: immediately before and after implantation of prosthetic valve (intraprocedural)
REPA
Reservoir-Excess Pressure Analysis (REPA): This method decomposes the measured aortic pressure waveform into a reservoir pressure (Pr), reflecting the global arterial storage and compliance dynamics, and an excess pressure (Pxs), representing the dynamic, wave-related component of the pulse. Parameters such as P-infinity (Pinf) serve as proxies for microcirculatory closing pressures.
Measured: Immediately before and after implantation of prosthetic valve (intraprocedural)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies 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
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serkan Aslan, Istanbul Mehmet Akif Ersoy Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509554
- Sponsor's protocol ID
- PREDIC-TAVI-IMAEH
- Acronym
- PREDIC-TAVI
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: may be considered based on reasonable request after discussion with IRB
Publications
Tas A, Alan Y, Ozcan A, Parker KH, van de Hoef T, Sezer M, Piek JJ. Ventricular-Coronary Interaction Delay is Associated With Discordance Between Fractional Flow Reserve and Coronary Flow Reserve in Intermediate Coronary Stenoses. Am J Cardiol. 2025 Aug 1;248:80-88. doi: 10.1016/j.amjcard.2025.04.003. Epub 2025 Apr 11.
PubMed 40222466Michail M, Hughes AD, Comella A, Cameron JN, Gooley RP, McCormick LM, Mathur A, Parker KH, Brown AJ, Cameron JD. Acute Effects of Transcatheter Aortic Valve Replacement on Central Aortic Hemodynamics in Patients With Severe Aortic Stenosis. Hypertension. 2020 Jun;75(6):1557-1564. doi: 10.1161/HYPERTENSIONAHA.119.14385. Epub 2020 Apr 20.
PubMed 32306768Rolandi MC, Wiegerinck EM, Casadonte L, Yong ZY, Koch KT, Vis M, Piek JJ, Baan J Jr, Spaan JA, Siebes M. Transcatheter Replacement of Stenotic Aortic Valve Normalizes Cardiac-Coronary Interaction by Restoration of Systolic Coronary Flow Dynamics as Assessed by Wave Intensity Analysis. Circ Cardiovasc Interv. 2016 Apr;9(4):e002356. doi: 10.1161/CIRCINTERVENTIONS.114.002356.
PubMed 27001805Abbas AE, Mando R, Kadri A, Khalili H, Hanzel G, Shannon F, Al-Azizi K, Waggoner T, Kassas S, Pilgrim T, Okuno T, Camacho A, Selberg A, Elmariah S, Bavry A, Ternacle J, Christensen J, Gheewala N, Pibarot P, Mack M. Comparison of Transvalvular Aortic Mean Gradients Obtained by Intraprocedural Echocardiography and Invasive Measurement in Balloon and Self-Expanding Transcatheter Valves. J Am Heart Assoc. 2021 Oct 5;10(19):e021014. doi: 10.1161/JAHA.120.021014. Epub 2021 Sep 29.
PubMed 34585593Naidu S, Chen T, Fiorilli P, Li RH, Desai N, Szeto WY, Giri J, Kobayashi T, Atluri P, Herrmann HC. Measuring TAVR Prosthesis Gradient Immediately Post-Procedure May Underestimate its Significance. JACC Cardiovasc Interv. 2022 Jan 10;15(1):120-121. doi: 10.1016/j.jcin.2021.09.012. No abstract available.
PubMed 34991821Yordanov TR, Al-Farra H, Ravelli ACJ, Houterman S, de Mol BA, Winkelman TA, Timmers L, Vis M, Tonino P, Delewi R, Abu-Hanna A, Henriques JPS; NHR THI Registration Committee. Incidence and trends of patient MACE outcomes after Transcatheter Aortic Valve Implantation (TAVI): analysis by age and sex. Neth Heart J. 2026 Jan;34(1):36-44. doi: 10.1007/s12471-025-02006-6. Epub 2025 Dec 17.
PubMed 41405821Baron SJ, Magnuson EA, Lu M, Wang K, Chinnakondepalli K, Mack M, Thourani VH, Kodali S, Makkar R, Herrmann HC, Kapadia S, Babaliaros V, Williams MR, Kereiakes D, Zajarias A, Alu MC, Webb JG, Smith CR, Leon MB, Cohen DJ; PARTNER 3 Investigators. Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2019 Dec 10;74(23):2833-2842. doi: 10.1016/j.jacc.2019.09.007. Epub 2019 Sep 29.
PubMed 31577923Osnabrugge RL, Arnold SV, Reynolds MR, Magnuson EA, Wang K, Gaudiani VA, Stoler RC, Burdon TA, Kleiman N, Reardon MJ, Adams DH, Popma JJ, Cohen DJ; CoreValve U.S. Trial Investigators. Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial. JACC Cardiovasc Interv. 2015 Feb;8(2):315-323. doi: 10.1016/j.jcin.2014.08.016.
PubMed 25700755Reynolds MR, Magnuson EA, Wang K, Thourani VH, Williams M, Zajarias A, Rihal CS, Brown DL, Smith CR, Leon MB, Cohen DJ; PARTNER Trial Investigators. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012 Aug 7;60(6):548-58. doi: 10.1016/j.jacc.2012.03.075. Epub 2012 Jul 18.
PubMed 22818074Arnold SV, Spertus JA, Vemulapalli S, Li Z, Matsouaka RA, Baron SJ, Vora AN, Mack MJ, Reynolds MR, Rumsfeld JS, Cohen DJ. Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population: A Report From the STS/ACC Transcatheter Valve Therapy Registry. JAMA Cardiol. 2017 Apr 1;2(4):409-416. doi: 10.1001/jamacardio.2016.5302.
PubMed 28146260
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07509554
- Acronym / sponsor ID
- PREDIC-TAVI / PREDIC-TAVI-IMAEH
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, TAVR, AORTIC STENOSIS, wave intensity analysis, reservoir excess pressure analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training HospitalOther government
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 3 Apr 2026 (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.
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.
Detailed description
Background and Rationale:
Severe Aortic Stenosis (AS) is characterized by the progressive calcification and narrowing of the aortic valve leaflets, leading to a significant mechanical obstruction in the Left Ventricular Outflow Tract (LVOT). While Transcatheter Aortic Valve Replacement (TAVR) has become the gold standard for high-risk and increasingly intermediate-to-low-risk patients, the clinical response remains heterogeneous. Current procedural success is primarily evaluated using steady-flow metrics such as Mean Pressure Gradient (MG) and Aortic Valve Area (AVA). However, the total workload on the Left Ventricle (LV) is not merely a function of valvular resistance but also involves pulsatile components including arterial compliance, wave reflections, and valvulo-arterial impedance. In many TAVR candidates, concomitant systemic arterial stiffness and reduced vascular compliance complicate the hemodynamic profile, making traditional gradients insufficient to fully characterize the true obstructive load and ventricular performance, e.g. in certain disease endotypes subgroups "paradoxical" low-flow, low-gradient (LFLG) phenotypes.
The PREDIC-TAVI study utilizes state-of-the-art wave mechanics to provide a granular assessment of the cardiovascular system's response to TAVR:
- Wave Intensity Analysis (WIA): By analyzing simultaneous changes in pressure and flow (or flow-surrogates), WIA identifies the energy flux of forward-traveling waves (Forward Compression Waves [FCW] generated by LV ejection and Forward Expansion Waves [FEW] during relaxation) and backward-traveling waves (Backward Compression Waves [BCW] reflected from the systemic tree and the stenotic valve).
- Reservoir-Excess Pressure Analysis (REPA): This method decomposes the measured aortic pressure waveform into a reservoir pressure (Pr), reflecting the global arterial storage and compliance dynamics, and an excess pressure (Pxs), representing the dynamic, wave-related component of the pulse. Parameters such as P-infinity (Pinf) serve as proxies for microcirculatory closing pressures.
Study Design and Procedural Methodology: This is a prospective, single-center, observational cohort study. Consecutive patients (aged 60-90 years) with a multidisciplinary "Heart Team" diagnosis of severe AS and a clinical indication for TAVR will be enrolled. The study employs a high-fidelity "pressure-only" approach for hemodynamic analysis. During the routine TAVR procedure, proximal aortic pressure waveforms will be recorded via fluid-filled catheters at a minimum sampling rate of 100 Hz. Recordings will be captured at two specific time points:
- Baseline (Pre-Implantation): Immediately prior to valve deployment under stable hemodynamic conditions.
- Post-Implantation: Following valve deployment and stabilization. Data acquisition occurs within the standard clinical workflow, requiring no additional invasive maneuvers. Waveforms are analyzed offline using standardized signal-processing algorithms (Savitzky-Golay filtering, beat segmentation, and diastolic exponential fitting) to derive delta-WIA and delta-REPA metrics.
Longitudinal Follow-up and Clinical Endpoints: The study aims to correlate acute intra-procedural hemodynamic changes with multidimensional clinical outcomes at three distinct follow-up intervals:
- 1-Month Follow-up (30 ± 5 days):
- 6-Month Follow-up (180 ± 14 days):
- 12-Month Follow-up (1 Year ± 3 weeks):
Primary Outcome Measures:
- Clinical Improvement: Assessed via the change in health-related quality of life using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index scores and Visual Analog Scale (VAS).
- Major Adverse Cardiovascular Events (MACE): A composite of all-cause mortality, stroke (major/minor), myocardial infarction, and unplanned hospitalizations due to heart failure or valve dysfunction, classified according to Valve Academic Research Consortium 3 (VARC-3) criteria. All cause mortality and any ED admissions are separately assessed.
Statistical Analysis Plan: The relationship between hemodynamic deltas and clinical outcomes will be analyzed using Pearson/Spearman correlations and linear regression. To account for the longitudinal follow-up and baseline clinical covariates (e.g., age, gender, comorbidities, and baseline LVEF), Generalized Linear Mixed Models (GLMM) will be utilized. Receiver Operating Characteristic (ROC) curves and Area Under the Curve (AUC) values will be calculated to determine the predictive power of wave-based metrics for 1-year MACE. OR/HR will be calculated for endpoints.
Sample Size Rationale: Based on current literature, TAVR is expected to significantly increase FCW energy and Pxs. To detect a moderate correlation (r=0.35) between these changes and the EQ-5D-5L index with 80% power and 5% alpha, a minimum of 62 patients is required. To ensure robust 1-year MACE prediction (assuming a 28% event rate in the TAVR population per SWEDEHEART registry data) and to account for technical or follow-up attrition, a target enrollment of at least 100 consecutive patients is established.
Scientific Contribution: The PREDIC-TAVI-IMAEH study seeks to define a new "physiological success" signature for TAVR. By moving beyond static gradients, this research aims to improve the diagnostic and prognostic algorithms for severe AS, providing clinicians with sensitive markers to optimize valve deployment and better anticipate the recovery trajectory of complex cardiovascular patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI | – | Procedure: Transcatheter aortic valve replacement (TAVR / TAVI)Patient with severe aortic stenosis who are clinical candidates for TAVI based on multidisciplinary heart team evaluation. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with inclusion criteria who are clinical candidates for TAVI based on multidisciplinary heart team evaluation.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve replacement (TAVR / TAVI)TAVI is performed as per standard procedural guidelines | Procedure or surgery | TAVI |
Primary outcome
EQ-5D-5L
Time frame: baseline at admission, at 1 month, 6 months and 12 months follow up
The 5-level EQ-5D version (EQ-5D-5L) measures health related quality of life
MACE
Time frame: at 1 month, 6 months and 12 months follow up
MACE (defined by VARC-3) will be monitored via electronic health records and telephone-visits.
WIA
Time frame: immediately before and after implantation of prosthetic valve (intraprocedural)
Wave Intensity Analysis (WIA): By analyzing simultaneous changes in pressure and flow (or flow-surrogates), WIA identifies the energy flux of forward and backward-traveling waves with their temporal and amplitude features.
REPA
Time frame: Immediately before and after implantation of prosthetic valve (intraprocedural)
Reservoir-Excess Pressure Analysis (REPA): This method decomposes the measured aortic pressure waveform into a reservoir pressure (Pr), reflecting the global arterial storage and compliance dynamics, and an excess pressure (Pxs), representing the dynamic, wave-related component of the pulse. Parameters such as P-infinity (Pinf) serve as proxies for microcirculatory closing pressures.
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 3 Apr 2026.
- Background: PubMed 40222466Tas A, Alan Y, Ozcan A, Parker KH, van de Hoef T, Sezer M, Piek JJ. Ventricular-Coronary Interaction Delay is Associated With Discordance Between Fractional Flow Reserve and Coronary Flow Reserve in Intermediate Coronary Stenoses. Am J Cardiol. 2025 Aug 1;248:80-88. doi: 10.1016/j.amjcard.2025.04.003. Epub 2025 Apr 11.
- Background: PubMed 32306768Michail M, Hughes AD, Comella A, Cameron JN, Gooley RP, McCormick LM, Mathur A, Parker KH, Brown AJ, Cameron JD. Acute Effects of Transcatheter Aortic Valve Replacement on Central Aortic Hemodynamics in Patients With Severe Aortic Stenosis. Hypertension. 2020 Jun;75(6):1557-1564. doi: 10.1161/HYPERTENSIONAHA.119.14385. Epub 2020 Apr 20.
- Background: PubMed 27001805Rolandi MC, Wiegerinck EM, Casadonte L, Yong ZY, Koch KT, Vis M, Piek JJ, Baan J Jr, Spaan JA, Siebes M. Transcatheter Replacement of Stenotic Aortic Valve Normalizes Cardiac-Coronary Interaction by Restoration of Systolic Coronary Flow Dynamics as Assessed by Wave Intensity Analysis. Circ Cardiovasc Interv. 2016 Apr;9(4):e002356. doi: 10.1161/CIRCINTERVENTIONS.114.002356.
- Background: PubMed 34585593Abbas AE, Mando R, Kadri A, Khalili H, Hanzel G, Shannon F, Al-Azizi K, Waggoner T, Kassas S, Pilgrim T, Okuno T, Camacho A, Selberg A, Elmariah S, Bavry A, Ternacle J, Christensen J, Gheewala N, Pibarot P, Mack M. Comparison of Transvalvular Aortic Mean Gradients Obtained by Intraprocedural Echocardiography and Invasive Measurement in Balloon and Self-Expanding Transcatheter Valves. J Am Heart Assoc. 2021 Oct 5;10(19):e021014. doi: 10.1161/JAHA.120.021014. Epub 2021 Sep 29.
- Background: PubMed 34991821Naidu S, Chen T, Fiorilli P, Li RH, Desai N, Szeto WY, Giri J, Kobayashi T, Atluri P, Herrmann HC. Measuring TAVR Prosthesis Gradient Immediately Post-Procedure May Underestimate its Significance. JACC Cardiovasc Interv. 2022 Jan 10;15(1):120-121. doi: 10.1016/j.jcin.2021.09.012. No abstract available.
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- Individual participant dataSharing planned: Undecided. may be considered based on reasonable request after discussion with IRB
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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, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Apr 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 Turkey (Türkiye). 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 Serkan Aslan, Ass. Prof MD (+90(212) 692 20 00, drserkanaslan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-5L (time frame: baseline at admission, at 1 month, 6 months and 12 months follow up). The study lists 4 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 NCT07509554, which also lists 10 linked publications.
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 3 Apr 2026.