AltaValve System for Mitral Regurgitation

Recruiting at 32 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 4C Medical Technologies, Inc.

Must not be taking: Heparin, Warfarin

Disqualifiers: Pregnancy, Cognitive issues, Low LVEF, others

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

Compensation: Varies

Number of Visits: 31

Duration: Day 0

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the AltaValve System, a new treatment for mitral regurgitation, a condition where the heart's mitral valve doesn't close tightly, causing blood to flow backward. The trial aims to determine if the AltaValve can safely improve symptoms in those with moderate-to-severe cases who cannot undergo surgery or another common procedure. Participants are divided into two groups: one without significant calcification (buildup of calcium) around the valve and another with it. Ideal participants are adults with noticeable symptoms affecting daily life who have found other treatments ineffective. As an unphased trial, this study offers patients the opportunity to explore a potentially effective treatment option when other treatments have failed.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have moderate-to-severe mitral regurgitation despite optimal guideline-directed medical therapy, which suggests you may need to continue your current treatment.

What prior data suggests that the AltaValve System is safe for treating mitral regurgitation?

Research has shown that the AltaValve System has been tested in several clinical settings. One study found that the system worked well in all patients, with most experiencing significant improvement in their leaky heart valve condition. At discharge, 80% of patients had no or only slight leakage, while 20% had mild leakage. This outcome suggests that the treatment was generally well-tolerated.

Another review of clinical data on the AltaValve System highlights its safety. The system is designed to be securely placed above the natural mitral valve, eliminating the need for direct attachment to heart tissue. This design could reduce the risk of complications during the procedure.

While these findings are promising, clinical trials are still ongoing. Participants should discuss any concerns with their healthcare providers to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for mitral regurgitation (MR) include medications to manage symptoms or surgical interventions like valve repair or replacement. The AltaValve System is unique because it offers a minimally invasive approach to treat moderate-to-severe MR, potentially reducing the need for open-heart surgery. Researchers are excited about it because it can be used in patients with or without significant mitral annular calcification (MAC), expanding treatment options for broader patient populations. Additionally, its innovative design aims to improve valve function and patient outcomes with fewer complications and a faster recovery time than traditional surgical methods.

What evidence suggests that the AltaValve System is effective for mitral regurgitation?

Research shows that the AltaValve System may help treat mitral regurgitation (MR), a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. This trial includes two separate cohorts: the Primary Cohort, which evaluates the AltaValve System in patients without at least moderate mitral annular calcification (MAC), and the Mitral Annular Calcification Cohort (MAC), which focuses on patients with moderate to severe MAC. Studies have found that the AltaValve can significantly reduce MR, with patients moving from severe to little or no MR. In some trials, all participants underwent successful procedures without major complications. The AltaValve has also shown good results in patients with severe MAC, improving heart function. While early results are promising, more research is needed to confirm its long-term effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate-to-severe or severe mitral regurgitation who still have symptoms despite optimal medical treatment. They should be unsuitable for surgery and other specific heart valve repairs as assessed by a heart team.

Inclusion Criteria

I have heart symptoms that affect my daily activities.

My heart valve condition is severe despite taking all recommended medications.

I have been deemed unsuitable for heart surgery or TEER by my medical team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AltaValve System for the treatment of mitral regurgitation

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 30 days, 6 months, 1 year, and annually thereafter

What Are the Treatments Tested in This Trial?

Interventions

• AltaValve System

Trial Overview The AltaValve System is being tested in this study to see if it's safe and works well for treating mitral regurgitation. The trial involves multiple centers, where participants are observed after receiving the intervention.

How Is the Trial Designed?

Group I: Primary Cohort Experimental Treatment 1 Intervention

Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC).

Group II: Mitral Annular Calcification Cohort (MAC) Experimental Treatment 1 Intervention

Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC.

Who Is Running the Clinical Trial?

4C Medical Technologies, Inc.

Lead Sponsor

Trials

2

Recruited

470+

Published Research Related to This Trial

The Carillon Mitral Contour System was evaluated in a real-world setting with 101 patients, showing significant reductions in mitral regurgitation and improvements in heart failure symptoms over 5 years, similar to results from controlled trials.

Despite a 40.1% all-cause mortality rate and a 53.9% incidence of heart failure hospitalizations, the therapy demonstrated a favorable safety profile and potential benefits for patients with functional mitral regurgitation, including those previously excluded from clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CINCH-FMR postmarket registry: Real-world long-term outcomes with percutaneous mitral valve repair with the Carillon Mitral Contour System®. Yildiz, M., Haude, M., Sievert, H., et al.[2023]

In a study of 74 patients with functional mitral regurgitation treated with the Carillon device, the 5-year survival rate was 56.2%, indicating a favorable long-term outcome for this population.

Key factors associated with improved long-term survival included a decrease in NYHA class, increased distance on the 6-minute walk test, and reduced regurgitant volume within the first year after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Lipiecki, J., Kaye, DM., Witte, KK., et al.[2021]

The Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System is being evaluated for its efficacy in treating mitral regurgitation, a common but often untreated heart valve condition, in a randomized trial against traditional surgical valve replacement.

There is optimism that transcatheter mitral interventions could significantly change how severe symptomatic mitral regurgitation is managed, despite existing challenges in integrating these new treatments into standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Implantation with the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System. Koh, JQ., Walton, A., Marasco, S., et al.[2020]

Surgical intervention for severe functional mitral regurgitation is effective and can be performed using traditional or minimally invasive techniques, both yielding similar outcomes for patients who are suitable for surgery.

Transcatheter mitral valve replacement is a promising new technology for patients at high surgical risk, with early studies on devices like Tendyne, Intrepid, and Evoque showing encouraging results in treating mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical versus transcatheter mitral valve replacement in functional mitral valve regurgitation. Scott, EJ., Rotar, EP., Charles, EJ., et al.[2022]

In a study involving 30 high-risk patients with chronic mitral regurgitation, the MitraClip® procedure achieved acute procedural success in 86.7% of cases without any major adverse events within 30 days.

At the 30-day follow-up, 86.7% of patients showed a reduction in mitral regurgitation severity to ≤2+, and 96.7% improved to NYHA class I/II, indicating significant improvements in heart function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVJ-514 Trial　- Baseline Characteristics and 30-Day Outcomes Following MitraClip® Treatment in a Japanese Cohort. Hayashida, K., Yasuda, S., Matsumoto, T., et al.[2022]

The MitraClip system, an endovascular technique for treating severe mitral regurgitation, has been successfully used in over 35,000 patients and is effective in improving survival and quality of life while reducing rehospitalization rates.

Despite its effectiveness, there is still significant undertreatment of patients with severe mitral regurgitation in Italy, particularly among those who are not eligible for surgery, highlighting a need for better access to the MitraClip procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcatheter mitral valve repair for patients not amenable to surgical correction: epidemiology, diagnosis, equiti of access, and economic impact]. Bedogni, F., Berti, S., Esposito, G., et al.[2019]

Chronic mitral regurgitation (MR) affects over 4 million people in the U.S., and untreated MR can lead to serious health issues, making effective treatment crucial.

The MitraClip edge-to-edge repair system, inspired by surgical techniques, is currently the most advanced and effective transcatheter approach for treating MR, offering a safer alternative for patients who may be at high surgical risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous mitral valve repair: The MitraClip device. Suradi, HS., Kavinsky, CJ., Hijazi, ZM.[2020]

The MitraClip percutaneous system is a promising treatment for patients with significant mitral regurgitation (MR) who are at high surgical risk, having been successfully used in over 35,000 patients since its introduction.

Randomized trials, including EVEREST II, MITRA-FR, and COAPT, indicate that the MitraClip improves survival and quality of life, emphasizing the importance of careful patient selection and the experience of the treatment center for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations on the use of MitraClip in the treatment of mitral regurgitation. Musumeci, G., Rossini, R.[2020]

The MitraClip system is a safe and effective option for treating severe mitral regurgitation in high-risk patients who have previously undergone cardiac surgery, as demonstrated in two case studies.

Both patients experienced a significant and sustained reduction in mitral regurgitation severity over a two-year follow-up, along with improvements in their clinical status and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous mitral valve repair in patients with prior cardiac surgery. Scandura, S., Ussia, GP., Caggegi, A., et al.[2016]

The MitraClip Transcatheter Mitral Valve Repair system has been shown to be safe and effective for treating symptomatic degenerative mitral regurgitation in high-risk patients, with over 4,000 patients treated in the U.S. and more than 35,000 worldwide since its approval in 2013.

Real-world data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry indicate that the MitraClip may be even safer and more effective than results from initial clinical trials, highlighting its potential for broader use in various patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Repair of Mitral Regurgitation. Barker, CM.[2019]

Transcatheter mitral valve repair with the MitraClip system is a safe and effective treatment option for patients with severe mitral regurgitation who are at high risk for traditional surgery.

The article reviews essential clinical and imaging factors for selecting patients and guiding the procedure, providing practitioners with updated insights based on current literature and clinical experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic evaluation and guidance for MitraClip procedure. Katz, WE., Conrad Smith, AJ., Crock, FW., et al.[2020]

The MitraClip procedure was successfully performed on 115 high-risk patients with a low 30-day mortality rate of 2.6%, demonstrating its safety as a treatment for mitral valve regurgitation.

Patients experienced significant improvements in their condition, with 80.7% showing reduced mitral regurgitation at discharge and 81% reporting better functional status one month after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state of transcatheter mitral valve repair with the MitraClip. Downs, EA., Lim, DS., Saji, M., et al.[2020]

In a study of 194 patients undergoing transcatheter mitral valve repair with the MitraClip System, the observed mortality rates after 1 and 2 years were similar to those predicted by established heart failure models, indicating that the procedure is generally safe for patients with moderate-to-severe symptomatic heart failure.

However, patients with end-stage heart failure and very high NTproBNP levels (>10,000 pg/ml) experienced significantly higher mortality rates than predicted, suggesting that this subgroup may not benefit from MitraClip therapy and faces a higher risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival after MitraClip(®) therapy in patients with severe mitral regurgitation and severe congestive heart failure: A comparison among survivals predicted by heart failure models. Schau, T., Isotani, A., Neuss, M., et al.[2018]

In a study of 139 high-surgical-risk patients with severe mitral valve regurgitation, those treated with the MitraClip transcatheter repair showed similar 1-year survival rates (85.8%) as those who underwent traditional surgery (85.2%), despite having a higher surgical risk.

Both the transcatheter repair and surgical groups had significantly better survival rates compared to patients receiving conservative treatment (67.7%), indicating that transcatheter repair is a viable alternative for patients who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients. Swaans, MJ., Bakker, AL., Alipour, A., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40527709/

The AltaValve system for transcatheter mitral valve ... While early outcomes are promising, the data are limited to small, non-randomized cohorts, and long-term durability remains to be established.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553838925002945

The AltaValve system for transcatheter mitral valve ... Efficacy outcomes. Early clinical experience with the AltaValve system demonstrates good efficacy in reducing MR, improving hemodynamics, and enhancing ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.124.014985?doi=10.1161/CIRCINTERVENTIONS.124.014985

Transcatheter Mitral Valve Replacement With Atrial ... Technical success and mitral regurgitation reduction from severe to none/trace were achieved in all cases. There were no cases of left ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11121746/

AltaValve Atrial Fixation System for the Treatment of ... AltaValve demonstrated positive procedural outcomes in 6 patients with severe mitral annular calcification. •. AltaValve demonstrated resolution of mitral ...

5. jacc.org jacc.org/doi/10.1016/j.jcin.2025.01.379

700.01 The AltaValve Early Feasibility Study: 6-Month ... Technical success was achieved in 97% of cases. Post-procedural assessment showed none/trace MR in 100% of subjects and a MV mean gradient of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06465745

Study Details | NCT06465745 | AltaValve Pivotal Trial Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2474870624000253

AltaValve Atrial Fixation System for the Treatment of ... Technical success was achieved in all patients. Median follow-up was 232 days. At discharge, 80% of patients had none/trace MR, and 20% had mild MR.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40340705/

Evaluating the AltaValve as a novel method for ... The AltaValve System features a supra-annular design, ensuring secure fixation in the left atrium above the native mitral valve annulus without anchoring ...