V-Wave Shunt After MitraClip for Heart Failure

Overseen By Samir Kapadia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must be taking: RAS inhibitors, Beta-blockers

Disqualifiers: Severe pulmonary hypertension, COPD, 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: 7

Duration: Immediate post-procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the V-Wave Shunt, for individuals who have undergone a MitraClip procedure to address mitral valve issues. The goal is to determine if this device can safely manage heart failure symptoms. The trial seeks participants with persistent heart failure symptoms despite standard treatments and who have had a MitraClip procedure. Eligible participants should have experienced at least one hospital stay for heart failure in the past year or meet specific heart health criteria. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart failure management research.

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 be on stable heart failure medications for at least one month before joining the study, except for diuretics. It's best to discuss your specific medications with the study team.

What prior data suggests that the V-Wave Shunt is safe for heart failure patients?

Research has shown that the V-Wave Shunt is generally safe for people with heart failure. In earlier studies, patients with heart failure who received this device experienced 45% fewer heart-related problems compared to those who did not. Another study found no major issues with the device or the procedure within 30 days after implantation. The shunt remained open and functioned well in all patients observed. These findings suggest the V-Wave Shunt is well-tolerated and safe for treating heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The V-Wave Shunt is unique because it offers a novel approach to managing heart failure, particularly after a MitraClip procedure. Unlike standard treatments that mainly focus on medications or more invasive surgeries, the V-Wave Shunt provides a less invasive way to improve heart function by directing blood flow more efficiently. Researchers are excited because it could potentially enhance quality of life for patients with heart failure by reducing symptoms more effectively and quickly than current options.

What evidence suggests that the V-Wave Shunt is effective for heart failure?

Research has shown that the V-Wave Shunt, which participants in this trial will receive, might help reduce pressure on the heart by creating a small opening between the heart's upper chambers. This could improve heart function and lessen symptoms of heart failure. Studies suggest that devices like the V-Wave Shunt can lead to better outcomes for heart failure by reducing stress on the heart. Although specific data on the V-Wave Shunt is limited, its design aims to improve heart function by relieving pressure, offering promise for patients with heart failure. ^{2 3 4 6 7}

Who Is on the Research Team?

Samir Kapadia

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients with symptomatic secondary mitral valve regurgitation due to heart issues, who have had at least one hospitalization for heart failure or high BNP levels. They must be eligible for MitraClip therapy and not suitable for mitral valve surgery. Exclusions include severe pulmonary hypertension, recent strokes or surgeries, certain types of cardiomyopathies, active infections, and known allergies to nickel.

Inclusion Criteria

Clinical eligibility for MitraClip: Symptomatic secondary MR (moderate-severe [3+ or 4+] or greater) due to ischemic or non-ischemic cardiomyopathy, NYHA functional class III, or ambulatory IV, maximization of GDMT as directed by the 'Heart Team', including an interventional cardiologist (implanting physician), heart failure cardiologist, and cardiothoracic surgeon, receiving Class I recommended cardiac rhythm management device therapy, at least one hospitalization for heart failure in last year OR corrected BNP ≥ 300 pg/mL or corrected NTproBNP ≥ 1500 pg/mL, heart team has determined that mitral valve (MV) surgery will not be offered as a treatment option, Anatomic eligibility for MitraClip: LVEF ≥ 20% and ≤ 50%, LV end-systolic dimension ≤ 70 mm, MV orifice area > 4.0 cm2 by TEE, minimal calcification in the grasping area, no leaflet cleft in the grasping area, in patients with a degenerative component to MR, the following additional criteria must be met: flail width <15 mm, flail gap <10 mm, the primary regurgitant jet is non-commissural, and in the opinion of the implanting investigator can be successfully be treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant), transseptal catheterization and femoral vein access is feasible per investigator, provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.

I am eligible for a MitraClip procedure for my heart valve issue.

Exclusion Criteria

I do not have severe heart or lung conditions, recent major heart procedures, or a life expectancy under 1 year due to non-cardiac conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of the V-Wave Shunt device following MitraClip procedure

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular visits at 6 months, 1 year, 2 years, 3 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• V-Wave Shunt Placement

Trial Overview The study tests the safety and feasibility of implanting a V-Wave Interatrial Shunt in patients immediately after they've received a MitraClip procedure. The goal is to see if this shunt can help reduce left atrial filling pressures in these heart failure patients.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

V-Wave Shunt Placement

V-Wave Shunt Placement is already approved in United States for the following indications:

Approved in United States as V-Wave Interatrial Shunt System for:

• Heart Failure with Reduced Ejection Fraction (HFrEF)

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

samir kapadia

Lead Sponsor

Trials

2

Recruited

360+

V-Wave Ltd

Industry Sponsor

Trials

5

Recruited

650+

Published Research Related to This Trial

In a study of 103 patients with severe mitral regurgitation undergoing MitraClip procedure, right ventricular dysfunction (RVD) was found to significantly increase one-year mortality risk, with a mortality rate of 34.8% in RVD patients compared to 2.8% in those without RVD.

The Seattle Heart Failure Model (SHFM) showed better prognostic accuracy for predicting one-year mortality in patients without RVD, while both SHFM and the MAGGIC score had comparable prognostic power in patients with RVD, highlighting the importance of RVD as a prognostic marker.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential prognostic accuracy of right ventricular dysfunction, the Seattle heart failure model and the MAGGIC score in patients with severe mitral regurgitation undergoing the MitraClip® procedure. Heyl, S., Luu, B., Wieszner, M., et al.[2022]

The MitraClip device is effective and safe for treating symptomatic organic mitral regurgitation, especially in patients who are poor candidates for surgery.

However, it can lead to acute left ventricular systolic failure due to afterload mismatch, highlighting the importance of rapid diagnosis and treatment, as demonstrated in a case where transesophageal echocardiography was crucial for identifying the issue during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Hypotension After MitraClip Implantation due to Acute Left Ventricular Failure. Dalia, AA., Essandoh, M.[2018]

In a study of 92 patients with severe mitral regurgitation who underwent MitraClip therapy, the procedure resulted in a significant 60.1% reduction in mitral valve area (MVA), which was linked to changes in pulmonary hypertension and patient outcomes.

A postprocedural MVA of 1.94 cm² or less was found to be an independent predictor of increased risk for all-cause mortality and heart failure hospitalization, highlighting the importance of MVA assessment in predicting patient prognosis after the MitraClip procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Percutaneous Edge-to-Edge Repair on Mitral Valve Area and Its Association With Pulmonary Hypertension and Outcomes. Utsunomiya, H., Itabashi, Y., Kobayashi, S., et al.[2017]

The MitraClip device is FDA-approved for treating severe degenerative mitral regurgitation in patients who cannot undergo surgery, and it is being studied for severe functional mitral regurgitation.

In a challenging case where the posterior leaflet of the mitral valve was restricted, using a pigtail catheter helped successfully position the MitraClip by bringing the leaflets closer together, demonstrating a potential technique for interventionalists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pushing with the pigtail: a novel approach to placing the MitraClip in a patient with a severely restricted posterior mitral leaflet. Jones, BM., Tuzcu, EM., Kapadia, SR.[2016]

In a study involving 6 pigs, a negative logarithmic relationship was found between the duration of induced ventricular fibrillation (VF) and the rate of recovery of systolic blood pressure (SBP), indicating that longer VF durations negatively affect heart function.

Cardiovascular collapse occurred unpredictably during VF trials, but the use of epinephrine was effective in reversing this collapse, highlighting the need for careful monitoring during implantable cardioverter defibrillator procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systolic arterial pressure recovery after ventricular fibrillation in pigs. Amirhamzeh, MM., Jia, CX., Park, WM., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914924004594

Design and Rationale of the V-Wave Shunt MitraClip Study The V-Wave Shunt MitraClip Study is a prospective study with the intent to implant the V-Wave shunt device after MitraClip in 10 patients.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.070870

Interatrial Shunt Treatment for Heart Failure An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis.

3. vwavemedical.com vwavemedical.com/vwave/clinical_research/

Clinical Research This study is assessing the safety and effectiveness of the V-Wave® Ventura® Interatrial Shunt for the treatment of heart failure (HF).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12576559/

Efficacy and safety of interatrial shunt treatment for heart ... This systematic review and meta-analysis evaluated their efficacy and safety across multiple clinical outcomes. While short-term benefits were ...

5. jacc.org jacc.org/doi/10.1016/j.jcmg.2025.08.005

Mechanistic Basis for Differential Effects of Interatrial Shunt ... This study aims to examine differences in cardiac structure and function before and after interatrial shunt placement in patients with HFrEF vs ...

6. vwavemedical.com vwavemedical.com/v-wave-announces-late-breaking-primary-results-from-pivotal-double-blind-randomized-controlled-relieve-hf-trial-of-the-ventura-interatrial-shunt-showing-reduced-clinical-events-in-advanced-he/

V-Wave Announces Late-Breaking Primary Results from ... Heart failure patients with reduced ejection (HFrEF) had 45% fewer adverse cardiovascular events, whereas patients with heart failure with preserved ejection ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2020.09.462

TCT CONNECT-434 Success, Safety, and Patency of the V ... Implantation of the V-Wave Ventura Interatrial Shunt has been successful in all patients and safe, with 100% shunt patency to date.