Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip

NCT04729933 | Active Not Recruiting FDA Device

• 2 other identifiers: G200329IRB 21-068
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Mitral Regurgitation

Outcome Measures

Primary Outcomes (6)

• All-cause death

  Number of death caused by any condition

  Up to 1 month post implant

• Stroke/paradoxical embolism

  Number of patients who developed stroke/paradoxical embolism

  Up to 1 month post implant

• Myocardial infarction

  Number of patients who developed MI

  Up to 1 month

• V-Wave shunt device embolization

  Number of V-Wave shunt device embolization occurrence

  Up to 1 month

• Cardiac Tamponade

  Number of occurrence of cardiac tamponade

  Up to 1 month

• Device related re-intervention or surgery

  Occurrence of device related re-intervention of surgery

  Up to 1 month

Secondary Outcomes (6)

• All-cause death

  At 6 months, 1 year, 2 years, 3 years and 5 years

• Stroke/paradoxical embolism

  At 6 months, 1 year, 2 years, 3 years and 5 years

• Myocardial infarction

  At 6 months, 1 year, 2 years, 3 years and 5 years

• V-Wave shunt device embolization

  At 6 months, 1 year, 2 years, 3 years and 5 years

• Cardiac Tamponade

  At 6 months, 1 year, 2 years, 3 years and 5 years

Study Arms (1)

Treatment

EXPERIMENTAL

V-Wave Shunt Placement

Device: V-Wave Shunt Placement

Interventions

V-Wave Shunt Placement DEVICE

After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients must meet clinical and anatomic eligibility for commercial placement of MitraClip for functional MR, as specified by the MitraClip Instructions for Use (IFU).
• a. Clinical eligibility for MitraClip: i. Symptomatic secondary MR (moderate-severe \[3+ or 4+\] or greater) due to ischemic or non-ischemic cardiomyopathy ii. NYHA functional class III, or ambulatory IV iii. Maximization of GDMT as directed by the "Heart Team", including an interventional cardiologist (implanting physician), heart failure cardiologist, and cardiothoracic surgeon. This includes adequate treatment for systolic HF (LV dysfunction), rhythm disorders, and coronary disease, if applicable
• An inhibitor of the reninangiotensin system (RAS inhibitor), including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and a beta-blocker (BB)
• Other medications recommended for selected populations, e.g., mineralocorticoid receptor antagonist (MRA) or nitrates/hydralazine should be used in appropriate patients, according to the published guidelines.
• Patient has been on stable HF medications as determined by the investigator, for at least 1 month, with the exception of diuretic therapy. Stable is defined as no more than a 100% increase or 50% decrease in dose within these periods.
• Drug intolerance, contraindications, or lack of indications must be attested to by the investigator.
• Receiving Class I recommended cardiac rhythm management device therapy.
• If indicated by class I guidelines, cardiac resynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to device implantation
• These criteria may be waived if a patient is clinically contraindicated for these therapies or refuses them and must be attested to by the investigator.
• iv. At least one hospitalization for heart failure in last year OR corrected BNP ≥ 300 pg/mL or corrected NTproBNP ≥ 1500 pg/mL v. Heart team has determined that mitral valve (MV) surgery will not be offered as a treatment option b. Anatomic eligibility for MitraClip: i. LVEF ≥ 20% and ≤ 50% ii. LV end-systolic dimension ≤ 70 mm iii. MV orifice area \> 4.0 cm2 by TEE iv. Minimal calcification in the grasping area v. No leaflet cleft in the grasping area vi. In patients with a degenerative component to MR, the following additional criteria must be met:
• Flail width \<15 mm
• Flail gap \<10 mm vii. 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) viii. Transseptal catheterization and femoral vein access is feasible per investigator 2. Provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.

You may not qualify if:

• Severe pulmonary hypertension, defined as RV systolic pressure or PA systolic pressure \> 70 mmHg, or PVR \> 4 Woods units, measured by any modality (TTE, TEE, cardiac MRI, or pulmonary artery catheterization \[if data available\]).
• Moderate or severe RV dysfunction defined as TAPSE \<12mm or RVFAC ≤25% as assessed on Baseline TTE, or qualitative assessment of severe RV dysfunction on TTE, TEE, or cardiac MRI.
• Untreated severe (3+ to 4+) tricuspid or pulmonary regurgitation.
• Untreated clinically significant coronary disease requiring revascularization
• Coronary artery bypass grafting, percutaneous coronary intervention, transcatheter aortic valve implantation, or CRT-D implantation within 30 days
• Aortic or tricuspid valve requiring surgery or transcatheter intervention
• COPD requiring continuous home oxygen therapy or chronic outpatient steroid use
• Cerebrovascular accident within prior 30 days
• Known severe symptomatic carotid stenosis
• Carotid surgery or stenting within prior 30 days
• ACC/AHA Stage D heart failure
• Presence of any of the following:
• Hypertrophy cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
• Infiltrative cardiomyopathy (e.g. amyloidosis, hemochromatosis, sarcoidosis)
• Leaflet anatomy which may preclude MitraClip implantation

Sponsors & Collaborators

• samir kapadia: lead
• V-Wave Ltd: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Officials

• Samir Kapadia, M. D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Principal Investigator

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: March 11, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)