TMVR for Mitral Valve Disease

(INTERLUDE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Caisson Interventional LLC

Disqualifiers: Severe mitral stenosis, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Intra-operative

75 Participants Needed

Trial Summary

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 Transcatheter Mitral Valve Replacement (TMVR) for Mitral Valve Disease?

TMVR is a new treatment option for severe mitral regurgitation (a condition where the heart's mitral valve doesn't close tightly), and early experiences show it can be done successfully, although the number of cases is still small. It has been used for patients who can't have surgery, and while it shows promise, more studies are needed to confirm its safety and effectiveness. ^{1 2 3 4 5}

Is transcatheter mitral valve replacement (TMVR) generally safe for humans?

TMVR is a newer technology with some risks, including complications like device dislocation, blood clots, and stroke. However, recent studies suggest it has acceptable safety for patients who are at high surgical risk, though more research is needed to improve its safety profile. ^{6 7 8 9 10}

How is the treatment TMVR for Mitral Valve Disease different from other treatments?

Transcatheter Mitral Valve Replacement (TMVR) is a new treatment option for severe mitral valve issues, especially for patients who are not good candidates for traditional surgery. Unlike conventional surgery, TMVR is performed using a catheter (a thin tube) to replace the valve, which can be less invasive and is currently being tested for its effectiveness and safety. ^{2 5 11 12 13}

What is the purpose of this trial?

The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

Research Team

Mat Williams, M.D.

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

This trial is for individuals at high risk for heart surgery with severe, symptomatic mitral regurgitation and classified as NYHA Class II-IVa. It's not suitable for those with excessive calcification of the mitral valve, severe right ventricular dysfunction, recent stroke or heart attack, or certain other heart conditions.

Inclusion Criteria

I have severe leakage in my heart's mitral valve.

My heart condition limits my physical activity.

I am at high risk for heart surgery.

Exclusion Criteria

I have a blockage in the heart affecting blood flow.

I have not had a stroke in the last 90 days.

I have not had a stroke or heart attack in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients with symptomatic mitral regurgitation are treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System

Intra-operative

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Transcatheter Mitral Valve Replacement

Trial Overview The study is evaluating a Transcatheter Mitral Valve Replacement (TMVR) system to treat severe mitral regurgitation. The goal is to determine how safe and effective this minimally invasive procedure is in improving heart function.

Participant Groups

Group I: Transcatheter Mitral Valve Replacement Experimental Treatment 1 Intervention

Patients with symptomatic mitral regurgitation (garde 3 or 4), determined to be a high risk for cardiovascular surgery, will be treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System

Who Is Running the Clinical Trial?

Caisson Interventional LLC

Lead Sponsor

Trials

2

Recruited

100+

Findings from Research

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]

Transcatheter mitral valve replacement (TMVR) is a promising new option for treating severe primary mitral regurgitation (MR) in patients at high surgical risk, showing feasibility in early trials with over 100 patients.

TMVR may provide more effective and consistent reduction of MR compared to traditional transcatheter mitral valve repair methods, but further studies with larger patient groups are necessary to establish safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges. Regueiro, A., Granada, JF., Dagenais, F., et al.[2020]

Transcatheter mitral valve replacement (TMVR) using a new self-expanding valve was successfully performed in 50 high-risk patients with symptomatic severe mitral regurgitation, achieving a high device implant success rate of 96%.

At a median follow-up of 173 days, 79% of patients showed significant improvement in their symptoms, with mild or no residual mitral regurgitation confirmed by echocardiography, indicating the procedure's efficacy in enhancing patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Experience With New Transcatheter Mitral Valve Replacement. Bapat, V., Rajagopal, V., Meduri, C., et al.[2022]

Transcatheter mitral valve replacement (TMVR) shows high procedural success in patients with severe mitral regurgitation who are at high surgical risk, indicating it could be a valuable alternative to traditional surgery.

Despite its promise, TMVR faces challenges such as potential left ventricular outflow tract obstruction and thrombotic risks, highlighting the need for further studies on long-term outcomes and optimal anticoagulation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Catheter-based Mitral Valve Replacement. Rawish, E., Schmidt, T., Eitel, I., et al.[2021]

Transcatheter mitral valve repair (TMVR) is a safer option than surgical mitral valve repair (SMVR) for older patients and those with more comorbidities, showing lower rates of complications such as permanent pacemaker implantation and major bleeding.

Despite being older and having higher comorbidity scores, TMVR patients experienced shorter hospital stays and were less likely to be discharged to skilled nursing facilities compared to those undergoing SMVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes. Jogu, HR., Arora, S., Strassle, PD., 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]

Transcatheter mitral valve replacement (TMVR) shows promise but is currently limited by complications such as left ventricle outflow tract obstruction and major bleeding from the transapical approach, which is the most common method used.

Recent observational studies indicate that TMVR can be performed with acceptable safety and efficacy, suggesting that with improved device design and delivery systems, its adoption in clinical practice could increase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of adverse outcomes after transcatheter mitral valve replacement. Overtchouk, P., Piazza, N., Granada, JF., et al.[2019]

Transcatheter mitral valve replacement (TMVR) in high-surgical-risk patients with severe mitral regurgitation showed significant improvements, with 93.2% of surviving patients having no mitral regurgitation at 2 years and a reduction in heart failure hospitalizations from 1.30 to 0.51 events per year post-procedure.

While the all-cause mortality rate was 39% over 2 years, with a notable 43.6% of deaths occurring within the first 90 days, the procedure led to sustained symptom improvement, with 81.6% of patients reporting NYHA functional class I or II at 2 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. Muller, DWM., Sorajja, P., Duncan, A., et al.[2022]

In a study of 400 high-risk patients with symptomatic mitral regurgitation undergoing transcatheter mitral valve replacement (TMVR), the procedure achieved a technical success rate of 95.2% and resulted in significant improvements in heart function over 2 years.

Despite the high success rate, the 2-year all-cause mortality rate was 38.1%, with chronic obstructive pulmonary disease and other health factors identified as predictors of mortality, highlighting the need for careful patient selection and management to enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. Ludwig, S., Perrin, N., Coisne, A., et al.[2023]

References

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

Transcatheter mitral valve replacement: an update. [2023]

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

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

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

Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry. [2023]

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

Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges. [2020]

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

Early Experience With New Transcatheter Mitral Valve Replacement. [2022]

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

Current Status of Catheter-based Mitral Valve Replacement. [2021]

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

30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. [2022]

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

Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes. [2021]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Predictors of adverse outcomes after transcatheter mitral valve replacement. [2019]

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

Five-year outcomes of transcatheter mitral valve implantation and redo surgery for mitral prosthesis degeneration. [2022]

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

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. [2022]

13. France pubmed.ncbi.nlm.nih.gov

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. [2023]