MRI-Guided Valve Replacement for Aortic Valve Stenosis

(MRI-TAVR Trial)

Overseen By LaStasha Cowan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Pacemakers, Defibrillators, Claustrophobia, Arrhythmia, others

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

Compensation: Varies

Number of Visits: 5

90 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{3 5 9 10 11}

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

Principal Investigator

UH, Cleveland Medical Center

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.

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

Group I: TAVR using the self-expanding valve Evolut FX Active Control 1 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 Ultra Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement. Habertheuer, A., Gleason, TG., Kilic, A., et al.[2021]

The Sapien 3 transcatheter heart valve (S3 THV) was successfully implanted in 54 high-risk patients with aortic stenosis, showing excellent clinical outcomes with 97.8% of patients experiencing no or mild aortic regurgitation at 30 days post-procedure.

The study reported a low incidence of complications, with only 3.7% of patients experiencing stroke or all-cause mortality, and all patients improved to New York Heart Association Functional Class I or II, indicating significant functional improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve. Wendt, D., Al-Rashid, F., Kahlert, P., et al.[2022]

In a study of 66 patients comparing two types of transcatheter aortic valves, the Evolut R valve consistently showed lower mean gradients than the Sapien 3 valve at all follow-up points (1 year, 6 months, and discharge), indicating better hemodynamic performance.

Smaller sizes of both valve types were associated with higher gradients, but the Evolut R valve maintained superior performance over the Sapien 3, suggesting that valve size and type significantly impact patient outcomes post-implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sahebjam, M., Zoroufian, A., Hajizeinali, A., et al.[2023]

In a study involving 995 patients, the new-generation Medtronic Evolut R prosthesis demonstrated a shorter procedure time and lower use of predilatation and contrast dye compared to the older CoreValve, indicating improved efficiency in the TAVI procedure.

Thirty-day clinical outcomes, including rates of complications and mortality, were similar between the Evolut R and CoreValve, suggesting that the new device is as safe and effective as its predecessor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. Noble, S., Stortecky, S., Heg, D., et al.[2020]

The Medtronic CoreValve Evolut R 34 mm, the largest self-expanding transcatheter heart valve, demonstrated a high procedural success rate of 92.1% in a study of 101 patients, indicating its efficacy in treating aortic stenosis.

The early safety profile was favorable, with a low 30-day mortality rate of 2.0% and a low incidence of major complications, including only 1.0% major vascular complications and 5.0% bleeding events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicentre registry. Kuhn, C., Frerker, C., Meyer, AK., et al.[2019]

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis who are at moderate to high surgical risk, demonstrating significant efficacy in clinical trials.

Newer-generation devices, such as the SAPIEN-3 and CENTERA valves, have shown improvements in reducing paravalvular leaks and achieving excellent clinical outcomes, indicating advancements in TAVI technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. Solomonica, A., Choudhury, T., Bagur, R.[2019]

Transcatheter aortic valve replacement (TAVR) is now a standard treatment for patients with severe aortic stenosis at intermediate risk for surgery, showcasing its growing acceptance in clinical practice.

The Evolut PRO system, a new self-expandable valve from Medtronic, represents significant advancements in TAVR technology, aimed at enhancing device quality and safety compared to earlier models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves. Mahtta, D., Elgendy, IY., Bavry, AA.[2023]

Transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 valve is a safe and effective alternative to traditional surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis, showing lower rates of complications.

Recent trials have demonstrated that the SAPIEN 3 valve significantly reduces vascular complications and paravalvular leakage, with lower stroke and mortality rates than expected in high-risk surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis. Htun, NM., Webb, JG.[2016]

In a study involving 177 patients who underwent transcatheter aortic valve replacement (TAVR), the self-expandable Portico valve and the balloon-expandable Sapien 3 valve showed similar short-term clinical outcomes, with no significant differences in 30-day mortality or major complications.

While procedural success rates were nearly identical (99.0% for Portico vs 98.6% for Sapien 3), the Sapien 3 valve required significantly less contrast dye and had a shorter fluoroscopy time, suggesting it may be more efficient in certain procedural aspects.

NCBI (Pubmed)

pubmed.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. Mas-Peiro, S., Seppelt, PC., Weiler, H., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement with a Self-Expanding Prosthesis. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Multicenter comparison of latest-generation balloon-expandable versus self-expanding transcatheter heart valves: Ultra versus Evolut. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve. [2022]

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

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]

6. France pubmed.ncbi.nlm.nih.gov

Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. [2020]

7. France pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicentre registry. [2019]

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

Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra. [2019]

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

From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of the Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis. [2016]

11. United States pubmed.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]