90 Participants Needed

MRI-Guided Valve Replacement for Aortic Valve Stenosis

(MRI-TAVR Trial)

LD
LC
Overseen ByLaStasha Cowan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment MRI-Guided Valve Replacement for Aortic Valve Stenosis?

Research shows that both the balloon-expandable Sapien 3 Ultra and the self-expanding Medtronic Evolut FX valves are effective for treating aortic valve stenosis, with improvements in safety and durability over time. The Sapien 3 valve has a low incidence of paravalvular leakage (a type of leak around the valve), and the self-expanding valves are noted for their excellent performance in patients with varying surgical risks.12345

Is the MRI-guided valve replacement for aortic valve stenosis safe?

Research shows that the newer-generation balloon-expandable and self-expanding valves, like the Edwards SAPIEN 3 Ultra and Medtronic Evolut, have been studied for safety and have shown good clinical outcomes with reduced complications such as paravalvular leak (a type of leakage around the valve). These devices have been used successfully in patients with severe aortic stenosis, indicating they are generally safe for human use.23678

How is the MRI-guided valve replacement treatment for aortic valve stenosis different from other treatments?

This treatment uses advanced transcatheter aortic valve replacement (TAVR) techniques with two types of valves: the balloon-expanding Edwards Sapien 3 Ultra and the self-expanding Medtronic Evolut FX. These valves are designed to be less invasive than traditional surgery, with features that reduce complications like vascular injury and leakage, making them suitable for patients at intermediate or high surgical risk.3591011

What is the purpose of this trial?

The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.

Research Team

Guilherme Attizzani, MD - University ...

Guilherme Attizzani, MD

Principal Investigator

UH, Cleveland Medical Center

SA

Sadeer Al-Kindi, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for adults with aortic valve stenosis who need a valve replacement and can undergo the procedure through their leg artery. They must be able to consent, have no severe heart issues like reduced heart function or untreated coronary disease, no history of valve replacements, and no implants that are unsafe for MRI.

Inclusion Criteria

I am over 18 and scheduled for a transfemoral TAVR procedure.
My heart team has decided I need a valve replacement due to aortic valve stenosis.
Able to give informed consent

Exclusion Criteria

I have untreated heart artery problems.
I have had a surgical aortic valve replacement or a valve-in-valve TAVR procedure.
My heart's pumping ability is reduced.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-TAVR MRI

CMR performed up to three months prior to the TAVR procedure to assess baseline cardiac function

Up to 12 weeks

TAVR Procedure

Participants undergo transcatheter aortic valve replacement with either the self-expanding valve Evolut FX or the balloon-expandable valve Sapien 3 Ultra

1 day
1 visit (in-person)

Post-TAVR Monitoring

Participants are monitored with echocardiography immediately post TAVR, 1-day post TAVR, and at 30-days post TAVR

30 days
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up CMR at 1-year

1 year
1 visit (in-person)

Treatment Details

Interventions

  • Balloon-expanding valve (Edwards Sapien 3 Ultra)
  • Self-expanding valve (Medtronic Evolut FX)
Trial Overview The study tests if self-expanding valves (Medtronic Evolut FX) provide better blood flow and exercise capacity compared to balloon-expanding valves (Edwards Sapien 3 Ultra), using stress cardiac MRI to measure differences in heart performance.
Participant Groups
2Treatment groups
Active Control
Group I: TAVR using the self-expanding valve Evolut FXActive Control1 Intervention
Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Medtronic Evolut FX supra-annular self-expanding valve
Group II: TAVR using the balloon-expandable valve Sapien 3 UltraActive Control1 Intervention
Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Edwards Sapien 3 Ultra valve

Balloon-expanding valve (Edwards Sapien 3 Ultra) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Edwards Sapien 3 Ultra for:
  • Severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency
🇪🇺
Approved in European Union as Edwards Sapien 3 Ultra for:
  • Severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency
  • Degenerated bioprosthetic aortic valve

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Guilherme Attizzani, MD

Lead Sponsor

Trials
1
Recruited
90+

Findings from Research

The self-expanding transcatheter heart valve (Medtronic Cardiovascular Corevalve and Evolut) has been significantly improved in design and technique, enhancing its safety, efficacy, and durability for patients with severe aortic stenosis.
This valve is particularly advantageous for patients with varying levels of surgical risk and preliminary data indicates that its durability is comparable to that of traditional surgical tissue valves.
Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis.Hughes, E., Grossman, PM.[2021]
In a study of 1612 patients undergoing transcatheter aortic valve replacement (TAVR), the SAPIEN 3 Ultra valve showed higher device success rates (92.7%) compared to the Evolut valve (87.6%), indicating better overall performance.
The Evolut valve was associated with a higher need for permanent pacemaker implantation (15.2% vs. 8.4%) and more frequent moderate paravalvular leakage (3.7% vs. 1.3%) compared to the Ultra valve, although it had fewer cases of elevated gradients.
Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut.Rheude, T., Pellegrini, C., Allali, A., et al.[2022]
In a study of 563 patients undergoing transcatheter aortic valve replacement (TAVR) with either balloon-expandable (BE) or self-expandable (SE) valves, the SE valves were associated with a higher risk of ischemic stroke at 30 days (6.0% vs 1.4%), although other outcomes like mortality and readmission rates were similar between the two types.
Midterm outcomes for both BE and SE valves were comparable, suggesting that while SE valves may pose a short-term stroke risk, overall survival and readmission rates do not significantly differ, indicating that patient selection based on clinical factors is important for optimal valve choice.
Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement.Habertheuer, A., Gleason, TG., Kilic, A., et al.[2021]

References

Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis. [2021]
Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut. [2022]
Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement. [2021]
Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve. [2022]
Comparison of 1-year Follow-up Echocardiographic Outcomes of Sapien 3 Versus Evolut R Bioprosthetic Transcatheter Aortic Valves: A Single-center Retrospective Iranian Cohort Study. [2023]
Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. [2020]
Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicentre registry. [2019]
Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. [2019]
From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves. [2023]
Evaluation of the Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
A Direct Comparison of Self-Expandable Portico Versus Balloon-Expandable Sapien 3 Devices for Transcatheter Aortic Valve Replacement: A Case-Matched Cohort Study. [2020]
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