Avalus Ultra Valve for Aortic Valve Disease

Not currently recruiting at 14 trial locations

Overseen By Jenell Lorenz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Surgery

Disqualifiers: Prosthetic valve, Systemic infection, Renal failure, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the Medtronic Avalus Ultra aortic valve for individuals with aortic valve disease, which includes issues like valve narrowing or leaking. The study targets those needing valve replacement and possibly facing related heart conditions, such as atrial fibrillation, or requiring procedures like coronary artery bypass surgery. It seeks participants with moderate to severe valve issues who can return for follow-ups at the implant location. As an unphased trial, it provides a unique opportunity to contribute to medical research and potentially benefit from advanced treatment.

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 prior data suggests that the Avalus Ultra valve is safe for aortic valve disease?

Research has shown that the Avalus Ultra aortic valve is generally safe for patients. Studies have found that patients tolerate this valve well, with positive outcomes reported over seven years, indicating its durability and effective function.

Real-world data from multiple centers also supports its safety. This data reveals few serious issues after implantation, and most patients do not experience severe side effects. Overall, the Avalus Ultra valve appears to be a safe choice for those needing a new aortic valve. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Avalus Ultra Valve is unique because it offers a new generation of bioprosthetic heart valves designed for treating aortic valve disease. Unlike mechanical valves, which require lifelong blood thinners, and traditional bioprosthetic valves, which may wear out sooner, the Avalus Ultra aims to offer improved durability with its advanced design and materials. Researchers are excited about its range of sizes (19mm to 29mm), making it suitable for a wide variety of patients, and its potential to provide better long-term outcomes without the need for ongoing medication. This innovation could lead to a higher quality of life for patients with aortic valve disease.

What evidence suggests that the Avalus Ultra valve is effective for aortic valve disease?

Research has shown that the Medtronic Avalus Ultra aortic valve, under study in this trial, effectively treats aortic valve disease. One study found that 91% of patients experienced improved heart function with this valve. No reports indicated valve failure or the need for additional surgeries. The valve also remained effective for over seven years without major issues. These results suggest that the Avalus Ultra is a promising option for patients requiring a new aortic valve. ^{1 3 5 6 7}

Who Is on the Research Team?

Juan Crestanello, MD

Principal Investigator

Mayo Clinic

Bo Yang, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with aortic valve disease who can undergo heart procedures like AF ablation or PFO closure. Participants must be able to return for follow-ups and give informed consent. It's not suitable for those unable to commit to the study requirements.

Inclusion Criteria

I understand the study's risks and am willing to consent.

I can travel for follow-up visits.

I am of legal age to make my own health decisions.

Exclusion Criteria

Subject is pregnant, lactating, or planning pregnancy during the study period

Subject has had a previous implant and explant of the Avalus Ultra aortic valve bioprosthesis within the Avalus Ultra Post-Approval Study

I have a heart valve device or need a valve repair.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with the Medtronic Avalus Ultra aortic valve bioprosthesis

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 year

Multiple visits (in-person) at 30 days and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Avalus Ultra

Trial Overview The Medtronic Avalus Ultra aortic valve bioprosthesis is being tested in this study. The goal is to assess its safety and effectiveness when used in patients needing treatment for conditions such as aortic valve stenosis.

How Is the Trial Designed?

Group I: Avalus Ultra Experimental Treatment 1 Intervention

Avalus Ultra bioprosthesis: sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm

Medtronic Avalus Ultra is already approved in United States, European Union for the following indications:

Approved in United States as Avalus Ultra for:

• Aortic valve disease
• Aortic stenosis
• Aortic regurgitation

Approved in European Union as Avalus Ultra for:

• Aortic valve disease
• Aortic stenosis
• Aortic regurgitation

Who Is Running the Clinical Trial?

Medtronic Cardiac Surgery

Lead Sponsor

Trials

10

Recruited

9,900+

Published Research Related to This Trial

In a study comparing the Avalus and Perimount Magna Ease bioprostheses in 96 patients undergoing aortic valve replacement, both showed similar hemodynamic performance over 5 years, with no significant differences in mean pressure gradient or effective orifice area.

Survival rates were also comparable at 5 years (88% for PME and 91% for Avalus), but the Avalus group had three cases requiring reoperation due to endocarditis, indicating a potential safety concern with that prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic Comparison between the Avalus and the Perimount Magna Ease Aortic Bioprosthesis up to 5 Years. Burri, M., Bozini, N., Vitanova, K., et al.[2022]

The Avalus™ bovine stented aortic valve bioprosthesis demonstrated a good safety profile and clinical effectiveness, with a 1-year survival rate of 96.4% among 686 patients, indicating it is a viable option for treating aortic stenosis and regurgitation.

While the valve showed low rates of serious complications like thromboembolism and endocarditis, there was a higher incidence of all and major hemorrhage, which may be linked to long-term anticoagulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Klautz, RJM., Kappetein, AP., Lange, R., et al.[2022]

The Medtronic Intact porcine bioprosthesis shows a high rate of freedom from structural valve deterioration, particularly in aortic valve replacements, with over 98% of patients aged 61-70 and older than 70 years remaining free from deterioration after 10 years.

The study, which included 1,272 patients over a 10-year period, found that early mortality rates were 7.3%, with higher rates associated with concomitant procedures, indicating that while the bioprosthesis is effective, patient age and additional surgeries can impact outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medtronic intact porcine bioprosthesis: 10 years' experience. Jamieson, WR., Lemieux, MD., Sullivan, JA., et al.[2019]

In a study of 500 patients undergoing aortic valve replacement with the Medtronic Freestyle stentless bioprosthesis, the procedure showed a 5.2% operative mortality rate, with no deaths in patients under 60 years, indicating a favorable safety profile especially in younger patients.

At eight years post-surgery, the Freestyle valve demonstrated excellent mid-term outcomes, including 100% freedom from structural valve deterioration and 97% freedom from reoperation, suggesting its efficacy as a long-term solution for aortic valve replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight-year results of Freestyle stentless bioprosthesis in the aortic position: a single-center study of 500 patients. Deleuze, PH., Fromes, Y., Khoury, W., et al.[2016]

A systematic review of 42 studies involving 12,842 elderly patients (average age 76.5 years) showed that aortic valve replacement (AVR) with bioprostheses has a low early mortality risk of 5.42% and low annual rates of thromboembolism (1.83%) and bleeding (0.75%).

The estimated life expectancy after AVR for a 75-year-old patient is about 9.8 years, which is comparable to the general population, indicating that bioprostheses are a safe and effective option for elderly patients needing AVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioprosthetic aortic valve replacement in elderly patients: Meta-analysis and microsimulation. Huygens, SA., Etnel, JRG., Hanif, M., et al.[2020]

In the PERIGON Japan Trial, 82% of the 11 patients who received the 17-mm Avalus bioprosthesis showed significant improvement in heart function after one year, meeting the primary endpoint of the study.

The trial demonstrated that the Avalus valve had a low incidence of device-related complications, with no reinterventions or device failures reported over two years, indicating its safety and effectiveness for patients undergoing aortic valve replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial. Okita, Y., Fujita, T., Zaikokuji, K., et al.[2022]

The INSPIRIS RESILIA Durability Registry (INDURE) aims to assess the long-term outcomes of the INSPIRIS RESILIA aortic valve in patients under 60 years old, with a follow-up period of 5 years and a target enrollment of at least 400 patients across multiple sites in Europe and Canada.

The primary goals of the study include evaluating valve safety at one year and monitoring for structural valve degeneration over five years, which will provide critical insights into the durability and performance of bioprosthetic valves in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. Meuris, B., Borger, MA., Bourguignon, T., et al.[2020]

In a study of 10,308 patients who underwent aortic and mitral valve replacements, bioprosthetic valves in the aortic position showed better long-term durability, with a lower reoperation rate (2.6%) compared to mitral valves (3.5%).

Patients with mitral valve replacements had a higher risk of all-cause death (36.5%) compared to those with aortic valve replacements (32.6%), indicating that aortic bioprosthetic valves may offer superior outcomes in terms of longevity and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of Biological Valves Implanted in Aortic or Mitral Positions: A Nationwide Cohort Study. Chen, CY., Lin, CP., Hung, KC., et al.[2023]

The Avalus™ stented bovine pericardial valve demonstrated good safety and effectiveness in Japanese patients undergoing surgical aortic valve replacement, with no in-hospital mortality and fewer severe patient-prosthesis mismatches compared to the Magna™ valve.

Both valves showed similar hemodynamic performance at 1 year postoperatively, but the Avalus™ valve was associated with a greater reduction in left ventricular mass index, suggesting potential long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of safety and haemodynamic performance between the Avalus™ stented aortic valve bioprosthesis and Magna™ valve in Japanese patients. Tadokoro, N., Fukushima, S., Shimahara, Y., et al.[2021]

Citations

1. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiovascular/heart-valves/tissue-valves-conduits/avalus-ultra-bioprosthesis.html

Avalus Ultra™ Bioprosthesis The KM event rate was 5.7% (4.3–7.7%) for reintervention, 6.3% (4.9–8.3%) for endocarditis, and 0.4% (0.1–1.1%) for valve thrombosis. Mean aortic gradient, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06506903

NCT06506903 | Avalus Ultra Post-Approval Study (PAS) The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39565905/

Seven-year outcomes after surgical aortic valve ... This analysis demonstrated excellent durability of the Avalus valve with good clinical outcomes and stable haemodynamic performance through 7 years of follow- ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170006B.pdf

summary of safety and effectiveness data (ssed) The Avalus™ bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. III. CONTRAINDICATIONS.

5. withpower.com withpower.com/trial/phase-aortic-valve-disease-9-2024-aff34

Avalus Ultra Valve for Aortic Valve Disease In one study, 91% of patients showed improvement in heart function, and there were no reinterventions or valve failures reported. Show more.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06506903

NCT06506903 | Avalus Ultra Post-Approval Study (PAS) The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve ...

7. medtronic.com medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiovascular/heart-valves/avalus-ultra-bioprosthesis-brochure.pdf

Avalus Ultra™ bioprosthesis Real-world data on the Avalus pericardial aortic valve: initial results from a prospective, multi-center registry. Presented at. Heart Valve Society 2024, ...