AltaValve System for Mitral Regurgitation

Recruiting at 30 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

Trial Summary

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 data supports the effectiveness of the AltaValve System treatment for Mitral Regurgitation?

While there is no direct data on the AltaValve System, similar treatments like the MitraClip system have shown effectiveness in improving survival and quality of life for patients with severe mitral regurgitation, especially those who are not suitable for surgery. The MitraClip system, which uses a less invasive approach, has been successfully used in over 35,000 patients and has demonstrated benefits in reducing hospital readmissions. ^{1 2 3 4 5}

Is the AltaValve System for Mitral Regurgitation safe for humans?

The safety of the MitraClip system, a similar transcatheter device for mitral valve repair, has been well-documented in high-risk patients, showing no major adverse events in a 30-day study and being considered safe in real-world settings. ^{6 7 8 9 10}

How is the AltaValve System treatment for mitral regurgitation different from other treatments?

The AltaValve System is a novel treatment for mitral regurgitation that likely offers a less invasive alternative to traditional surgical methods, similar to other transcatheter approaches like the MitraClip and Medtronic Intrepid systems. These systems are designed to address the unmet need for patients who are at high risk for surgery, providing a potential option for those who cannot undergo traditional surgical repair or replacement. ^{3 11 12 13 14}

What is the purpose of this trial?

This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

References

1. United States 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®. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

[Transcatheter mitral valve repair for patients not amenable to surgical correction: epidemiology, diagnosis, equiti of access, and economic impact]. [2019]

3. Qatar pubmed.ncbi.nlm.nih.gov

Percutaneous mitral valve repair: The MitraClip device. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Considerations on the use of MitraClip in the treatment of mitral regurgitation. [2020]

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

Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

AVJ-514 Trial　- Baseline Characteristics and 30-Day Outcomes Following MitraClip® Treatment in a Japanese Cohort. [2022]

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

Percutaneous Repair of Mitral Regurgitation. [2019]

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

Percutaneous mitral valve repair in patients with prior cardiac surgery. [2016]

9. China pubmed.ncbi.nlm.nih.gov

Current state of transcatheter mitral valve repair with the MitraClip. [2020]

10. Netherlands 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. [2018]

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

Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Implantation with the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System. [2020]

13. China pubmed.ncbi.nlm.nih.gov

Surgical versus transcatheter mitral valve replacement in functional mitral valve regurgitation. [2022]

14. China pubmed.ncbi.nlm.nih.gov

Echocardiographic evaluation and guidance for MitraClip procedure. [2020]