Valve Function Assessment After TAVR for Aortic Valve Stenosis

(ECHOCATH Trial)

Recruiting at 7 trial locations

Overseen By Josep Rodés-Cabau, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Disqualifiers: Stentless valves, Trifecta, Hancock II, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Periprocedural

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well two methods measure heart valve performance after a valve-in-valve transcatheter aortic valve replacement (TAVR), a procedure for treating aortic valve stenosis (a narrowed heart valve). It compares Doppler-echocardiography, which uses sound waves, with invasive hemodynamic measurements, which involve direct pressure readings inside the heart. The goal is to determine which method provides more accurate results. This trial may suit individuals who have previously undergone a surgical aortic valve replacement that is now failing and are approved for another procedure using the SAPIEN 3 Ultra valve. As an unphased trial, this study offers an opportunity to contribute to valuable research that could enhance future heart valve assessments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these assessment methods are safe for evaluating valve function?

Research shows that Doppler-echocardiography provides a safe and non-invasive way to assess heart valve function. Studies have found it useful for doctors to determine the severity of aortic stenosis (narrowing of the aortic valve). This method poses no major safety concerns, as it is non-invasive and widely used in medical settings.

For more detailed heart measurements, another method involves checking the pressures inside the heart and blood vessels. Experienced professionals generally perform this safely, although it is more invasive than Doppler-echocardiography. While any invasive procedure carries some risks, serious problems are rare. This method offers detailed information about heart function and aids doctors in making treatment decisions.

Both methods are generally well-tolerated, and serious side effects are uncommon. However, always discuss any concerns or questions with a healthcare provider when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different methods — Doppler-echocardiography and invasive hemodynamic measurements — to assess valve function after TAVR, a procedure for treating aortic valve stenosis. Unlike traditional follow-up methods that may not give as detailed a picture, Doppler-echocardiography offers a non-invasive way to evaluate blood flow and valve function using ultrasound waves. On the other hand, invasive hemodynamic measurements provide direct insights by recording aortic and ventricular pressures, potentially offering more precise data. By comparing these methods, researchers hope to improve patient outcomes by identifying the most effective way to monitor and guide further interventions after valve implantation.

What evidence suggests that this trial's methods could be effective for assessing valve function after TAVR?

Research shows that Doppler-echocardiography, one of the methods under study in this trial, effectively assesses the severity of aortic stenosis. Studies have found that it accurately predicts symptoms and outcomes in these cases. Specifically, Doppler readings showed a significant drop in pressure after TAVR, indicating improvement.

In contrast, invasive hemodynamic measurements, another method under study, offer an alternative way to assess aortic valve function. They can demonstrate immediate improvements in heart function after TAVR. However, results can vary, and some studies have reported mixed outcomes. This trial evaluates both methods to understand heart function after valve replacement. ^{5 6 7 8 9}

Who Is on the Research Team?

Josep Rodés-Cabau, MD

Principal Investigator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Are You a Good Fit for This Trial?

This trial is for patients with a failing surgical aortic valve who need a valve-in-valve procedure. They must have severe stenosis or regurgitation, and be suitable for the SAPIEN 3 Ultra valve. Excluded are those with non-stented valves, certain bioprostheses brands, high risk of coronary obstruction, or unable to consent.

Inclusion Criteria

My heart team approved me for a valve-in-valve procedure due to severe valve issues.

You have received the SAPIEN 3 Ultra valve for transcatheter aortic valve replacement (TAVR).

I have a small surgical heart valve implant.

Exclusion Criteria

This is not a complete criterion. It seems like "Trifecta bioprosthesis" is a term or a part of a sentence. Can you please provide more context or the full criterion so that I can help you accurately?

This criterion refers to a specific type of bioprosthetic heart valve called the Hancock II.

My heart valve surgery did not use stents or sutures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo valve-in-valve TAVR procedure with randomization to Doppler-echocardiography or invasive hemodynamic measurements for optimization

Periprocedural

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in quality of life and structural valve degeneration

1 year

Regular follow-up visits at 1 month, 12 months, and yearly up to 5 years

Long-term follow-up

Extended monitoring for structural valve degeneration and clinical safety endpoints

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Doppler-echocardiography
• Invasive hemodynamic measurements

Trial Overview

The study compares Doppler-echocardiography versus catheterization measurements in assessing heart valve performance after ViV-TAVR. It aims to determine which method gives more accurate data on the condition of the replaced valves.

How Is the Trial Designed?

Group I: Invasive hemodynamic measurements Experimental Treatment 1 Intervention

Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).

Group II: Doppler-echocardiography Experimental Treatment 1 Intervention

Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.

Who Is Running the Clinical Trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead Sponsor

Trials

26

Recruited

6,300+

Published Research Related to This Trial

Transcatheter aortic valve replacement (TAVR) is now the preferred treatment for severe aortic stenosis in patients at intermediate to high risk, highlighting its efficacy and safety compared to traditional surgical methods.

Understanding the haemodynamic changes during TAVR is crucial for recognizing potential complications, and this review provides essential insights into the correlation between haemodynamic tracings and echocardiographic Doppler waveforms during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter and Doppler waveform correlation in transcatheter aortic valve replacement. Kalra, A., Makkar, RR., Bhatt, DL., et al.[2021]

Echocardiography is essential for diagnosing valvular heart disease, particularly aortic stenosis, and is crucial for assessing left ventricular function and determining the appropriate prosthetic valve dimensions before implantation.

In the context of trans-catheter aortic valve replacement (TAVR), echocardiography plays a vital role in baseline assessment, intra-procedural guidance, and post-procedural follow-up, helping to identify complications and evaluate long-term valve function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern Use of Echocardiography in Transcatheter Aortic Valve Replacement: an Up-Date. Caldararu, C., Balanescu, S.[2020]

In a study of 61 low-risk patients with bicuspid aortic stenosis who underwent transcatheter aortic valve replacement (TAVR), there was zero mortality and no disabling strokes at 30 days, indicating a high level of safety for this procedure.

While 10% of patients showed signs of hypoattenuated leaflet thickening (a potential concern), it did not correlate with any adverse clinical events, suggesting that TAVR remains an effective option for treating this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis. Waksman, R., Craig, PE., Torguson, R., et al.[2021]

In a study of 11 patients with aortic stenosis, transthoracic Doppler echocardiography revealed abnormal coronary flow profiles, including reversed early systolic flow and delayed forward flow, which were reversed after aortic valve replacement.

The changes in coronary flow profiles post-surgery suggest that valve replacement improves left ventricular and aortic hemodynamics, potentially alleviating symptoms like angina, even when left ventricular hypertrophy remains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profiles of coronary blood flow velocity in patients with aortic stenosis and the effect of valve replacement: a transthoracic echocardiographic study. Kenny, A., Wisbey, CR., Shapiro, LM.[2019]

In a study of 574 adult patients undergoing aortic valve replacement for aortic stenosis, Doppler echocardiography significantly reduced the need for invasive hemodynamic cardiac catheterization, with only 42% of patients requiring it after the echocardiographic assessment.

The use of cardiac catheterization declined over the study period from 54% in 1990 to 35% in 1992, indicating that Doppler echocardiography provided sufficient diagnostic information, especially for patients with less severe aortic stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Doppler echocardiography on utilization of hemodynamic cardiac catheterization in the preoperative evaluation of aortic stenosis. Roger, VL., Tajik, AJ., Reeder, GS., et al.[2019]

Transcatheter aortic valve replacement (TAVR) significantly reduced clinical Doppler pressure in patients with aortic stenosis, but this did not consistently lead to improvements in valve dynamics or left ventricle (LV) hemodynamics, as seen in 4 out of 12 patients who experienced no change or an increase in LV workload post-procedure.

Despite group-level improvements in maximum LV pressure, TAVR did not decrease major principal stress on the aortic valve leaflets in 9 out of 12 patients, which could contribute to valve degeneration and failure, highlighting the need for careful monitoring of valve dynamics before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Doppler-exclusive non-invasive computational diagnostic framework for personalized transcatheter aortic valve replacement. Bahadormanesh, N., Tomka, B., Abdelkhalek, M., et al.[2023]

Doppler echocardiography is a non-invasive technique that provides direct hemodynamic data, allowing for accurate measurement of peak flow velocity and pressure gradients across stenotic valves, making it useful for screening conditions like pulmonic and aortic stenosis.

This technique is also effective in quantifying valve area in mitral stenosis, detecting valvular regurgitation, and evaluating prosthetic valve malfunction, thus offering a comprehensive approach to assessing valvular heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doppler echocardiography in the evaluation of valvular heart disease. Missri, JC.[2008]

Doppler echocardiography is a superior noninvasive technique for evaluating prosthetic heart valves, providing safe and repeatable quantitative assessments of valve function.

The study specifically evaluated the Doppler characteristics of various mechanical and tissue mitral prostheses in patients with clinically normal valve function, highlighting its effectiveness in monitoring these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doppler evaluation of prosthetic mitral valves. Planinc, D., Jerić, M., Mihatov, S., et al.[2017]

Dobutamine stress echocardiography (DSE) is a safe and feasible method for assessing patients with aortic stenosis (AS), as demonstrated in a study of 27 patients, where only mild side effects were reported in 59% of cases.

DSE significantly increased cardiac output, heart rate, systolic blood pressure, ejection fraction, and transvalvular mean gradient, while also showing an increase in valve area, indicating that DSE can provide valuable hemodynamic information even in patients with severe AS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dobutamine stress Doppler hemodynamics in patients with aortic stenosis: feasibility, safety, and surgical correlations. Lin, SS., Roger, VL., Pascoe, R., et al.[2019]

In a study of 974 patients who underwent TAVR, augmented mean arterial pressure (AugMAP) was found to be a strong independent predictor of one-year mortality, with levels below 102.5 mmHg indicating a threefold increased risk of death.

AugMAP outperformed the traditional Society of Thoracic Surgeons (STS) risk score in predicting post-TAVR mortality, suggesting it could be a valuable tool for clinicians to identify high-risk patients and improve their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement Prognostication with Augmented Mean Arterial Pressure. Chao, CJ., Agasthi, P., Seri, AR., et al.[2023]

In a study of 151 patients who underwent transcatheter aortic valve replacement (TAVR), the heart rate adjusted diastolic delta was found to be the only invasive hemodynamic measure significantly associated with total mortality, indicating its potential as a prognostic tool.

Patients with a heart rate adjusted diastolic delta of less than 25 mmHg/beats per minute had a much higher mortality rate of 50%, compared to 12.6% for those with higher values, suggesting that this measure could help identify patients at greater risk after TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Different Invasive Hemodynamic Measurements as a Prediction Tool for Mortality after Transcatheter Aortic Valve Replacement in Men: A Retrospective Observational Study. Bavry, AA., Aalaei-Andabili, SH., Karimi, A., et al.[2020]

Doppler echocardiography is a valuable noninvasive technique that provides direct hemodynamic data, particularly useful for assessing patients with valvular heart disease, including accurate predictions of pressure gradients across stenotic valves.

This technique can also help evaluate the presence and extent of valvular regurgitation and assess the integrity of multiple valves, making it an essential tool for routine evaluation in patients with known or suspected valvular heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of valvular heart disease by Doppler echocardiography. Pearlman, AS., Scoblionko, DP., Saal, AK.[2019]

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