Valve Function Assessment After TAVR for Aortic Valve Stenosis (ECHOCATH Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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.
Is the treatment in the trial 'Valve Function Assessment After TAVR for Aortic Valve Stenosis' promising?Yes, the treatment is promising. TAVR, or transcatheter aortic valve replacement, is shown to improve heart valve function and reduce pressure in the heart. It uses advanced imaging techniques like echocardiography and Doppler to guide and assess the procedure, making it effective for patients with aortic stenosis, even those at low risk.4781011
What safety data exists for TAVR valve function assessment?Doppler echocardiography is a safe, non-invasive method for assessing valve function, providing hemodynamic data that correlates well with invasive procedures. It is used to evaluate prosthetic heart valves and detect complications during TAVR. Studies have shown its feasibility and safety in assessing aortic stenosis and valve function, making it a valuable tool in TAVR procedures.12679
What data supports the idea that Valve Function Assessment After TAVR for Aortic Valve Stenosis is an effective treatment?The available research shows that using Doppler echocardiography, a type of ultrasound, is effective in assessing heart valve function after TAVR. It helps predict how well the heart is working by measuring blood flow and pressure changes. One study found that TAVR significantly reduced pressure in the heart, which is a positive outcome. This method is non-invasive, meaning it doesn't require surgery, and it provides important information that can help doctors make better treatment decisions. Compared to other methods, like invasive hemodynamic measurements, Doppler echocardiography is safer and still provides accurate data about heart valve function.3571112
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
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.
Exclusion Criteria
My heart valve surgery did not use stents or sutures.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Group I: Invasive hemodynamic measurementsExperimental Treatment1 Intervention
Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).
Group II: Doppler-echocardiographyExperimental Treatment1 Intervention
Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of CaliforniaSan Francisco, CA
South Broward Hospital Disctrict D/B/A Memorial Healthcare SystemHollywood, FL
William Beaumont HospitalRoyal Oak, MI
Mayo ClinicRochester, MN
More Trial Locations
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Who is running the clinical trial?
Institut universitaire de cardiologie et de pneumologie de Québec, University LavalLead Sponsor
References
Doppler evaluation of prosthetic mitral valves. [2017]For the evaluation of patients with prosthetic heart valves Doppler echocardiography is superior over other noninvasive techniques because it allows quantitative assessment of valve function. As a noninvasive method Doppler is safe, easily repeatable and provides haemodynamic data that closely correlate with parameters obtained by invasive procedures (Sagar et al., 1986: Simpson et al., 1986; Wilkins et al., 1986; Gibbs, 1987). The purpose of our study was to evaluate Doppler characteristics of mechanical and tissue mitral prostheses; Starr-Edwards, Björk-Shiley, Hall-Medtronic and Hancock in patients with clinically normal valve function.
Doppler echocardiography in the evaluation of valvular heart disease. [2008]Doppler echocardiography is a relatively new non-invasive technique which provides direct hemodynamic data that is complementary to M-Mode and 2-Dimensional echocardiography. This technique allows measurement of peak flow velocity through a stenotic valve and allows accurate prediction of the pressure gradient across the valve. It is a promising technique for screening patients with suspected pulmonic and aortic stenosis. It allows quantitation of gradient and valve area in patients with mitral stenosis. Doppler techniques are also valuable in detecting and semi-quantitating valvular regurgitation. Pulsed Doppler echocardiography is accurate in evaluating patients with multi-valvular disease. Finally, Doppler techniques are finding an important role in the evaluation of suspected prosthetic valve malfunction. In summary, Doppler echocardiography offers a complementary approach for direct evaluation of intracardiac hemodynamics in patients with valvular heart disease.
Assessment of valvular heart disease by Doppler echocardiography. [2019]Doppler echocardiography provides direct hemodynamic data that are often complementary to those demonstrated by M-mode and two-dimensional echocardiographic imaging. This relatively new noninvasive technique has a number of important uses in patients with valvular heart disease. In both adults and children, Doppler measures of peak flow velocity through a stenotic valve allow accurate prediction of the pressure gradient across the valve, and the technique has particular promise for screening patients with suspected aortic or pulmonic stenosis. In patients with mitral stenosis but parasternal short-axis images of limited quality, Doppler velocity measures can provide novel data about the pressure gradient and mitral orifice area. Doppler techniques can also provide direct evidence for or against the presence of valvular regurgitation, and several approaches allow clinically useful estimation of the extent of aortic, mitral, or tricuspid regurgitation. In patients with known disease of one cardiac valve, Doppler is accurate for evaluating the integrity of a second valve. Finally, Doppler techniques have great promise for defining the nature, and perhaps the severity, of suspected prosthetic valve malfunction. Hence, we believe that Doppler echocardiography should become a routine part of the noninvasive evaluation of patients with known or suspected valvular heart disease.
Profiles of coronary blood flow velocity in patients with aortic stenosis and the effect of valve replacement: a transthoracic echocardiographic study. [2019]To report the first non-invasive assessment by transthoracic Doppler echocardiography of coronary blood flow in patients with aortic stenosis and of the effects of valve replacement.
Effect of Doppler echocardiography on utilization of hemodynamic cardiac catheterization in the preoperative evaluation of aortic stenosis. [2019]To examine the use of Doppler echocardiography in preoperative assessment of aortic stenosis and to determine its effect on subsequent use of hemodynamic cardiac catheterization.
Dobutamine stress Doppler hemodynamics in patients with aortic stenosis: feasibility, safety, and surgical correlations. [2019]This study was designed to describe the experience of our center with the safety and feasibility of dobutamine stress echocardiography (DSE) in aortic stenosis (AS), to characterize the hemodynamic response to dobutamine infusion, and to examine the hemodynamic response in relation to the anatomic evaluation of the valve among patients who underwent valve replacement.
Comparison of Different Invasive Hemodynamic Measurements as a Prediction Tool for Mortality after Transcatheter Aortic Valve Replacement in Men: A Retrospective Observational Study. [2020]Hemodynamic measurements can assess for paravalvular aortic regurgitation after transcatheter aortic valve replacement (TAVR). This study compared the utility of different invasive hemodynamic measures in providing prognostic information.
Modern Use of Echocardiography in Transcatheter Aortic Valve Replacement: an Up-Date. [2020]Echocardiography is the cornerstone in the diagnosis of any valvular heart disease. The accurate diagnosis of aortic stenosis, the left ventricle function and the other heart valves evaluation are currently done by ultrasound alone. Prosthetic valve choice and dimensions prior to implantation can be done solely by proper use of echocardiography. The emergence of new methods to cure aortic stenosis such as trans-catheter aortic valve replacement (TAVR) emphasized the diagnostic value of cardiac ultrasound. The usefulness of echocardiography in TAVR can be divided in the baseline assessment (common to patients treated by conventional surgery), intra-procedural guidance of valve deployment and post-procedural follow-up. In the baseline diagnostic work-up echocardiography should allow proper assessment of low-gradient severe aortic stenosis and especially of "low-flow, low-gradient" aortic stenosis, as far the benefit of any valve intervention in these cases may be overshadowed by persistent ventricular dysfunction. "Classic" TAVR is performed with a trans-esophageal echocardiography probe in place, but recently intracardiac echocardiography (ICE) was advocated to reduce the need for general anesthesia. "Minimalist TAVR approach" recommends no echo-guidance and valve implantation by angiography alone. Post-TAVR echo assessment should allow prompt recognition of early complications and the severity of para-valvular leaks. Long term follow-up by echocardiography assesses prosthetic valve function, left ventricular functional recovery and the impact of the procedure on associated conditions (mitral regurgitation, pulmonary hypertension or tricuspid regurgitation). This article emphasizes the role of the cardiologist with ultrasound skills in the assessment of patients addressed to TAVR.
Transcatheter and Doppler waveform correlation in transcatheter aortic valve replacement. [2021]Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for treatment of severe aortic stenosis in patients at intermediate to high risk of perioperative mortality following surgical aortic valve replacement. Haemodynamic assessment is an integral part of the procedure, and it is crucial for the operator to have an in-depth understanding of the haemodynamic alterations that occur during balloon aortic valvuloplasty and transcatheter valve deployment. Comprehension of the haemodynamic tracings is also pivotal for early recognition of periprocedural complications. With expanding indications for TAVR, it is imperative for members of the structural heart team to have an in-depth, nuanced understanding of transcatheter haemodynamic waveforms and their correlation with echocardiographic Doppler waveforms that are obtained periprocedurally during TAVR. This review provides a collection of transcatheter haemodynamic tracings and their corresponding Doppler echocardiography correlates that are demonstrative of physiological alterations and pathological lesions (complications) that occur during TAVR.
Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Bicuspid Aortic Valve Stenosis. [2021]The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS).
A Doppler-exclusive non-invasive computational diagnostic framework for personalized transcatheter aortic valve replacement. [2023]Given the associated risks with transcatheter aortic valve replacement (TAVR), it is crucial to determine how the implant will affect the valve dynamics and cardiac function, and if TAVR will improve or worsen the outcome of the patient. Effective treatment strategies, indeed, rely heavily on the complete understanding of the valve dynamics. We developed an innovative Doppler-exclusive non-invasive computational framework that can function as a diagnostic tool to assess valve dynamics in patients with aortic stenosis in both pre- and post-TAVR status. Clinical Doppler pressure was reduced by TAVR (52.2 ± 20.4 vs. 17.3 ± 13.8 [mmHg], p
Transcatheter Aortic Valve Replacement Prognostication with Augmented Mean Arterial Pressure. [2023]Post-transcatheter aortic valve replacement (TAVR) patient outcome is an important research topic. To accurately assess post-TAVR mortality, we examined a family of new echo parameters (augmented systolic blood pressure (AugSBP) and arterial mean pressure (AugMAP)) derived from blood pressure and aortic valve gradients.