V-Wave Shunt After MitraClip for Heart Failure

Recruiting in Palo Alto (17 mi)

Overseen by Samir Kapadia

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

Must be taking: RAS inhibitors, Beta-blockers

Disqualifiers: Severe pulmonary hypertension, COPD, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following percutaneous mitral valve repair using the MitraClip system.

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.

How is the V-Wave Shunt Placement treatment different from other treatments for heart failure after MitraClip?

The V-Wave Shunt Placement is unique because it involves creating a small passage between the heart's upper chambers to help reduce pressure and improve blood flow, which is different from the MitraClip that focuses on repairing the mitral valve itself. This approach can potentially address issues like acute left ventricular failure that may arise after MitraClip implantation. ^{1 2 3 4 5}

Research Team

Samir Kapadia

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• V-Wave Shunt Placement (Interatrial Shunt)

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.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

V-Wave Shunt Placement

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

samir kapadia

Lead Sponsor

Trials

2

Recruited

360+

V-Wave Ltd

Industry Sponsor

Trials

5

Recruited

650+

Findings from Research

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 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]

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]

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]

References

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

Acute Hypotension After MitraClip Implantation due to Acute Left Ventricular Failure. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Systolic arterial pressure recovery after ventricular fibrillation in pigs. [2019]

3. Ireland 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. [2022]

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

Effect of Percutaneous Edge-to-Edge Repair on Mitral Valve Area and Its Association With Pulmonary Hypertension and Outcomes. [2017]

5. United States 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. [2016]