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Valve Function Assessment After TAVR for Aortic Valve Stenosis (ECHOCATH Trial)

N/A

Recruiting

Led By Josep Rodés-Cabau, MD

Research Sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team

Surgical stented bioprosthetic valve (label size ≤25 mm)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1-year follow-up (yearly up to 5 years)

Awards & highlights

ECHOCATH Trial Summary

This trial found that echocardiography may overestimate the severity of valve stenosis following ViV-TAVR, meaning that the reported incidence of procedural-device failure may be lower than what is actually occurring.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not directly related to side effects, there may be risks associated with both Doppler-echocardiography and invasive hemodynamic measurements such as discomfort or complications from catheter use.

ECHOCATH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I have a small surgical heart valve implant.

ECHOCATH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1-year follow-up (yearly up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 1-year follow-up (yearly up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1-year follow-up (yearly up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Quality of life (Efficacy)

Periprocedural complications (Safety)

Secondary outcome measures

Left ventricular structure

Changes in Quality of life

Clinical safety endpoints

+11 more

ECHOCATH Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University LavalLead Sponsor

18 Previous Clinical Trials

3,173 Total Patients Enrolled

3 Trials studying Aortic Valve Stenosis

1,664 Patients Enrolled for Aortic Valve Stenosis

Josep Rodés-Cabau, MDPrincipal InvestigatorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

5 Previous Clinical Trials

1,552 Total Patients Enrolled

3 Trials studying Aortic Valve Stenosis

917 Patients Enrolled for Aortic Valve Stenosis

Media Library

Doppler-echocardiography Clinical Trial Eligibility Overview. Trial Name: NCT05459233 — N/A

Aortic Valve Stenosis Research Study Groups: Doppler-echocardiography, Invasive hemodynamic measurements

Aortic Valve Stenosis Clinical Trial 2023: Doppler-echocardiography Highlights & Side Effects. Trial Name: NCT05459233 — N/A

Doppler-echocardiography 2023 Treatment Timeline for Medical Study. Trial Name: NCT05459233 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any space available for participants to join this research?

"Sadly, this medical trial is no longer recruiting participants. It was initially posted on October 1st 2022 but had its last update on September 19th 2022. Although the study has finished recruitment, there are 188 other trials actively seeking patients at present."

Answered by AI

What is the main aim of this research endeavor?

"This medical trial aims to evaluate the safety of a certain procedure over 12 months. Furthermore, it will assess potential structural valve degeneration by looking for strut fractures or deformation as well as wear and tear through echocardiography imaging. Additionally, quality of life will be evaluated using the KCCQ questionnaire which is composed of seven domains that measure symptom frequency, symptom burden, etc."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

3-year Outcomes After Valve-in-valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses

Webb, John G., Dale J. Murdoch, Maria C. Alu, Anson Cheung, Aaron Crowley, Danny Dvir, Howard C. Herrmann, et al.. 2019. “3-year Outcomes After Valve-in-valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2019.03.483.

Circulation: Cardiovascular InterventionsJournal

Valve-in-surgical-valve with SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality

Kaneko, Tsuyoshi, Raj R. Makkar, Amar Krishnaswamy, James Hermiller, Adam Greenbaum, Vasilis Babaliaros, Pinak B. Shah, et al.. 2021. “Valve-in-surgical-valve with SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality”. Circulation: Cardiovascular Interventions. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circinterventions.120.010288.

Interventional Cardiology ReviewJournal

Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside

Saxon, John T, Keith B Allen, David J Cohen, Adnan K Chhatriwalla, Saint Luke’s Mid America Heart Institute, Kansas City, MO, USA;, University of Missouri – Kansas City, Kansas City, MO, USA, Saint Luke’s Mid America Heart Institute, Kansas City, MO, USA;, et al.. 2017. “Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside”. Interventional Cardiology Review. Radcliffe Group Ltd. doi:10.15420/icr.2017:29:1.

Interventional Cardiology ReviewJournal