Avalus Ultra Valve for Aortic Valve Disease

Recruiting at 10 trial locations

Overseen By Maggie Haltvick

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medtronic Cardiac Surgery

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 disease.

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 Avalus Ultra Valve for Aortic Valve Disease?

In the PERIGON Japan Trial, 91% of patients showed improvement in heart function one year after receiving the Avalus bioprosthesis, and 82% met the primary effectiveness goal, indicating the treatment's effectiveness in improving heart valve function. ^{1 2 3 4 5}

Is the Avalus Ultra Valve safe for humans?

The Avalus Ultra Valve has been studied for safety in humans, with trials showing no valve-related deaths or device issues over two years. In one study, 91% of patients showed improvement in heart function, and there were no reinterventions or valve failures reported. ^{1 3 4 6 7}

What makes the Avalus Ultra Valve treatment unique for aortic valve disease?

The Avalus Ultra Valve is a new stented aortic valve bioprosthesis made from bovine pericardial tissue, designed to improve heart function in patients undergoing surgical aortic valve replacement. It has shown good safety and effectiveness, with a high percentage of patients experiencing improved heart function and no need for reintervention within two years. ^{1 3 4 8 9}

Research Team

Juan Crestanello, MD

Principal Investigator

Mayo Clinic

Bo Yang, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

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

Trial Timeline

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

Treatment Details

Interventions

• Medtronic Avalus Ultra (Bioprosthetic Valve)

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.

Participant Groups

Group I: Avalus Ultra Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Medtronic Cardiac Surgery

Lead Sponsor

Trials

10

Recruited

9,900+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Hemodynamic Comparison between the Avalus and the Perimount Magna Ease Aortic Bioprosthesis up to 5 Years. [2022]

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

Durability of Biological Valves Implanted in Aortic or Mitral Positions: A Nationwide Cohort Study. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. [2022]

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

Bioprosthetic aortic valve replacement in elderly patients: Meta-analysis and microsimulation. [2020]

6. England 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. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Medtronic intact porcine bioprosthesis: 10 years' experience. [2019]

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

Eight-year results of Freestyle stentless bioprosthesis in the aortic position: a single-center study of 500 patients. [2016]

9. Japan pubmed.ncbi.nlm.nih.gov

Comparison of safety and haemodynamic performance between the Avalus™ stented aortic valve bioprosthesis and Magna™ valve in Japanese patients. [2021]