AltaValve for Mitral Valve Regurgitation

Recruiting at 17 trial locations

Overseen By Adam Lawrence

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 4C Medical Technologies, Inc.

Must not be taking: Aspirin, Heparin, Warfarin

Disqualifiers: Pregnancy, Cognitive issues, Low LVEF, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Day 0

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a known allergy to aspirin, heparin, or Warfarin, you must have an adequate alternative medication.

What data supports the effectiveness of the AltaValve treatment for Mitral Valve Regurgitation?

The AltaValve system is designed for transcatheter mitral valve replacement (TMVR) and aims to address anatomical challenges that other TMVR devices face. While specific data on AltaValve's effectiveness is not provided, TMVR has shown potential as a safe and effective treatment for patients with severe mitral valve disease who are not suitable for surgery. ^{1 2 3 4 5}

Is the AltaValve system safe for humans?

The AltaValve system is designed for transcatheter mitral valve replacement (TMVR) and aims to address anatomical challenges in treating mitral valve regurgitation. While specific safety data for AltaValve is not detailed, TMVR procedures generally involve risks such as procedural invasiveness and the need for anticoagulation (blood-thinning medication). Randomized controlled trials are recommended to better understand the safety and effectiveness of TMVR devices like AltaValve. ^{3 5 6 7 8}

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

The AltaValve treatment is unique because it is designed to overcome anatomical challenges in transcatheter mitral valve replacement (TMVR), such as the complex shape of the mitral valve area and potential interactions with nearby heart structures, making it a promising option for patients who are not suitable for traditional surgery. ^{3 4 9 10 11}

Research Team

Philippe Genereux, MD

Principal Investigator

Morristown Medical Center

Vinayak Bapat, MD

Principal Investigator

Allina Health System

Eligibility Criteria

This trial is for adults over 18 with moderate to severe mitral valve regurgitation who are at high risk for open-heart surgery. Participants should have symptoms classified as NYHA II-IV and cannot be pregnant, planning pregnancy, or enrolled in other conflicting studies. They must not have allergies to nitinol or contrast media that can't be managed with medication.

Inclusion Criteria

Your healthcare professional has determined that you are at high risk for open-heart surgery.

I have moderate to severe heart condition symptoms.

You have a serious heart valve problem called severe MR, as confirmed by an echocardiogram.

Exclusion Criteria

Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.))

Your heart's pumping ability is very low, as shown by a test done within the past 90 days.

I have had a mitral valve repair or replacement that does not affect AltaValve placement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the AltaValve procedure for the treatment of mitral valve regurgitation

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the AltaValve procedure

30 days

2 visits (in-person)

Treatment Details

Interventions

• AltaValve

Trial Overview The AltaValve Early Feasibility Study is testing the safety and performance of the AltaValve device in treating mitral valve regurgitation without conventional open-heart surgery. It's a prospective, single-arm study across multiple centers focusing on high-risk patients.

Who Is Running the Clinical Trial?

4C Medical Technologies, Inc.

Lead Sponsor

Trials

2

Recruited

470+

Findings from Research

In a study of 12,415 patients undergoing transcatheter mitral valve repair (TMVr) with MitraClip, health status improved significantly from a mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 43.0 at baseline to 67.0 at 30 days, indicating the procedure's efficacy.

There was notable variability in health outcomes across 339 sites, with the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranging from 12.5% to 100%, primarily influenced by patients' baseline health status rather than procedural factors or site volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States. Malik, AO., Chhatriwalla, AK., Saxon, J., et al.[2021]

Transcatheter mitral valve replacement (TMVR) is a viable option for high-risk patients with failed mitral bioprosthetic valves (valve-in-valve, ViV) and annuloplasty rings (valve-in-ring, ViR), showing acceptable technical success rates of 92.3%.

However, patients undergoing ViR had significantly higher rates of complications, including life-threatening bleeding and acute kidney injury, as well as a higher 1-year mortality rate (28.7% vs. 12.6% for ViV), indicating that ViR procedures may carry greater risks compared to ViV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings. Yoon, SH., Whisenant, BK., Bleiziffer, S., et al.[2022]

The AltaValve system for transcatheter mitral valve replacement (TMVR) is designed to address the complex anatomical challenges associated with severe mitral regurgitation, potentially improving treatment options for high-risk surgical patients.

Initial human procedures with the AltaValve indicate promising features, such as avoiding engagement with the mitral annulus and left ventricular outflow tract, but further studies are needed to assess its feasibility and performance in various clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the AltaValve system for transcatheter mitral valve replacement: overview of its safety and efficacy. Alperi, A., Del Val, D., Ferreira-Neto, AN., et al.[2022]

Transcatheter mitral valve replacement (TMVR) is a promising new treatment for patients with severe mitral regurgitation who cannot undergo traditional surgery.

The Tendyne prosthesis used in TMVR has demonstrated effectiveness and safety in high-risk patients during short-term follow-up, making it a viable alternative for managing severe mitral valve disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement with Tendyne. Niikura, H., Gössl, M., Sorajja, P.[2020]

Mitral regurgitation (MR) is the most common type of heart valve disease, and while surgery is the standard treatment, many patients are at high risk for surgery.

Transcatheter mitral valve replacement (TMVR) is being explored as a safe and effective alternative for these high-risk patients, with early studies showing promising results in terms of feasibility and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest Advances in Transcatheter Mitral Valve Replacement. Hinohara, TT., Reardon, MJ., Goel, SS.[2022]

Transcatheter mitral valve replacement (TMVR) offers a promising solution for completely eliminating mitral regurgitation (MR), which is a significant advantage over less certain transcatheter repair methods like TEER.

The authors emphasize the importance of conducting randomized controlled trials (RCTs) to thoroughly evaluate the safety and effectiveness of TMVR compared to existing treatments, as well as to inform clinical practices and reimbursement policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement. Rogers, JH., Sorajja, P., Thourani, VH., et al.[2021]

The EVOQUE transseptal transcatheter mitral valve replacement (TMVR) system was successfully used in 14 patients with moderate to severe mitral regurgitation, achieving a technical success rate of 92.9%.

At 30 days post-procedure, 83.3% of patients had no mitral regurgitation, and 81.8% showed improved functional status, indicating that this less invasive approach may be effective for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System. Webb, J., Hensey, M., Fam, N., et al.[2021]

The Mi-thos TMVR system was successfully implanted in all 10 high-risk patients with severe mitral regurgitation, demonstrating a 100% intraoperative success rate without any periprocedural mortality or major complications during the 30-day follow-up.

All patients showed no or trace mitral regurgitation after the procedure, indicating effective valve function, with a median mitral valve gradient of 2.0 mmHg, suggesting that the Mi-thos TMVR system is a safe and feasible option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. Yang, Y., Chen, J., Dong, L., et al.[2023]

Transcatheter mitral valve replacement (TMVR) is a new treatment for severe mitral regurgitation, but it currently has a high 30-day mortality rate exceeding 30%, indicating significant risks associated with the procedure.

Despite its challenges, TMVR has shown promise in treating patients with degenerative mitral stenosis and failed mitral repairs, leading to ongoing multicenter registries aimed at improving device design and understanding the procedure's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. Sarkar, K., Reardon, MJ., Little, SH., et al.[2019]

In a study of 1824 patients undergoing transcatheter mitral valve repair with MitraClip™, those receiving one or two clips had better clinical outcomes compared to those who received three or more clips, indicating that fewer clips may lead to safer and more effective treatment.

The use of multiple MitraClip™ implants was associated with higher risks of in-hospital death and adverse long-term outcomes, such as increased rates of cardiac death and rehospitalization for heart failure, suggesting that multiple clips may not be the best option for patients with mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of one, two or multiple MitraClip™ for transcatheter mitral valve repair: insights from a 1824-patient multicenter study. Giordano, A., Ferraro, P., Finizio, F., et al.[2022]

In a study of 628 patients undergoing transcatheter mitral valve repair (TMVR), the procedure demonstrated a high immediate success rate of 95.4% and low in-hospital mortality of 2.9%, indicating it is a safe intervention for patients with significant mitral regurgitation.

At the 1-year follow-up, there was a sustained reduction in the severity of mitral regurgitation, with only 6.0% of patients experiencing severe regurgitation, suggesting that TMVR effectively improves long-term outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. Nickenig, G., Estevez-Loureiro, R., Franzen, O., et al.[2022]

References

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

Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States. [2021]

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

Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Device profile of the AltaValve system for transcatheter mitral valve replacement: overview of its safety and efficacy. [2022]

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

Transcatheter Mitral Valve Replacement with Tendyne. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Latest Advances in Transcatheter Mitral Valve Replacement. [2022]

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

Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement. [2021]

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

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System. [2021]

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

Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. [2023]

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

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. [2019]

10. Italy pubmed.ncbi.nlm.nih.gov

Implantation of one, two or multiple MitraClip™ for transcatheter mitral valve repair: insights from a 1824-patient multicenter study. [2022]

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

Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. [2022]