Valve Function Assessment After TAVR for Aortic Valve Stenosis

(ECHOCATH Trial)

Recruiting at6 trial locations

Overseen by Josep Rodés-Cabau, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Disqualifiers: Stentless valves, Trifecta, Hancock II, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new way to evaluate heart valve replacements in patients with small failing valves. It uses a minimally invasive procedure to place a new valve inside the old one and compares two methods of checking how well the new valve works.

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 data supports the effectiveness of the treatment Doppler-echocardiography, Doppler ultrasound, Echocardiography with Doppler, Invasive hemodynamic measurements, Catheterization measurements, Invasive hemodynamic assessment for Valve Function Assessment After TAVR for Aortic Valve Stenosis?

Doppler echocardiography is effective in assessing heart valve diseases by providing important information about blood flow and pressure across the heart valves, which helps in evaluating the success of treatments like TAVR. Invasive hemodynamic measurements can also predict outcomes after TAVR by assessing complications such as paravalvular aortic regurgitation. ^{1 2 3 4 5}

Is Doppler echocardiography safe for assessing valve function after TAVR?

Doppler echocardiography is a safe, non-invasive method for assessing heart valve function, and it is easily repeatable. It provides important data that closely matches what is obtained through more invasive procedures. ^{1 6 7 8 9}

How is the treatment TAVR for aortic valve stenosis different from other treatments?

TAVR (Transcatheter Aortic Valve Replacement) is unique because it is a minimally invasive procedure that replaces the aortic valve without the need for open-heart surgery. It uses a catheter to implant a new valve, which can be especially beneficial for patients who are at high risk for traditional surgery. ^{1 3 10 11 12}

Research Team

Josep Rodés-Cabau, MD

Principal Investigator

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

Eligibility Criteria

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.

I have a small surgical heart valve implant.

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

Exclusion Criteria

My heart valve surgery did not use stents or sutures.

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.

Trial Timeline

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

Treatment Details

Interventions

• Doppler-echocardiography (Procedure)
• Invasive hemodynamic measurements (Procedure)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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 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]

References

1. England 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Assessment of valvular heart disease by Doppler echocardiography. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A Doppler-exclusive non-invasive computational diagnostic framework for personalized transcatheter aortic valve replacement. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effect of Doppler echocardiography on utilization of hemodynamic cardiac catheterization in the preoperative evaluation of aortic stenosis. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement Prognostication with Augmented Mean Arterial Pressure. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Transcatheter and Doppler waveform correlation in transcatheter aortic valve replacement. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Dobutamine stress Doppler hemodynamics in patients with aortic stenosis: feasibility, safety, and surgical correlations. [2019]

8. England pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Doppler evaluation of prosthetic mitral valves. [2017]

10. Romania pubmed.ncbi.nlm.nih.gov

Modern Use of Echocardiography in Transcatheter Aortic Valve Replacement: an Up-Date. [2020]

11. England 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. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis. [2021]