Heart FailureNCT04729933
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
A study testing V-Wave Shunt Placement in people with Heart Failure and Mitral Regurgitation, run by samir kapadia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Mitral Regurgitation
- What is being tested?
- V-Wave Shunt Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2021to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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).
- 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.
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- 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.
- 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.
Who cannot join
- Preliminary Exclusion Criteria (PEC) - to assessed by the Preliminary Screen at the baseline visit:
- 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
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- 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
- Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
- Need for surgery within 12 months
- Life expectancy < 1 year due to non-cardiac conditions
- Status 1 for cardiac transplant or history of cardiac transplant
- Modified Rankin score ≥ 4 for disability
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
- Active infection requiring antibiotic therapy
- TEE is contraindicated or high risk
- Pregnant or planning pregnancy within 12 months
- Known hypersensitivity or contraindication to procedural medications that cannot be adequately treated
- Known allergy to nickel.
- Patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee, for which the reasons must be documented.
- Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.
- Final Exclusion Criteria (FEC) - Assessed by the Final Screening, performed at time of cardiac catheterization prior to device placement (Study Intervention Visit)
- Presence of severe pulmonary hypertension assessed by invasive hemodynamic measurement with pulmonary artery catheterization prior to MitraClip placement, defined as PA systolic pressure > 70 mmHg or PVR > 4 Woods units.
- Anatomical anomaly on TEE that precludes implantation of the study device across the interatrial communication created by the MitraClip procedure, including:
- A posterior rim between the septum secundum and aorta (i.e. aortic rim) of < 5 mm.
- Atrial septal aneurysm defined as ≥ 10 mm of phasic septal excursion into either atrium or a sum total excursion of ≥ 15 mm during the cardiorespiratory cycle, with a base of ≥ 15 mm.
- Moderate or worse MR ≥2+ at the end of MitraClip treatment (i.e. MR must be <2+ by TTE, TEE, invasive hemodynamics, or left ventriculography)
- Key hemodynamic exclusions after MitraClip treatment:
- Mean LAP ≤ 20 mmHg following final result from MitraClip placement (i.e. mean LAP must be elevated > 20 mmHg after completion of MitraClip).
- Difference between mean LAP and mean RAP < 5mmHg after MitraClip placement (i.e. difference between LAP - RAP must be ≥ 5 mmHg).
- If the patient meets these hemodynamic exclusion criteria and mean arterial pressure (MAP) is < 90 mmHg, the MAP may be increased to ≥ 90 mmHg and repeat pressure measurements obtained in order to evaluate eligibility.
- IV fluids and medications may be given to support MAP to a goal ≥ 90 mmHg if necessary.
- Characteristics of septal defect
- Angle of placement of V-WAVE shunt should be no more than 135 degrees to prevent slippage through the septum, and
- Septal defect created by MtrraClip delivery system must be 8mm or smaller, in any dimention, without evidence of a tear in the septum
- Patient is otherwise not appropriate for study as determined by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip: The V-Wave Shunt MitraClip Study
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.
Read the detailed description
The V-Wave Shunt is a device placed across the interatrial septum (IAS) by cardiac catheterization which allows for the transfer of blood from the left atrium (LA) to right atrium (RA). The intended effect is to reduce excessive left-sided cardiac filling pressures in patients with advanced heart failure (HF) and thus improve symptoms related to pulmonary congestion. All patients in the study must meet all anatomic and clinical eligibility in the FDA approved indications for use of the MitraClip in functional mitral regurgitation (MR). All patients must have persistence of New York Heart Association (NYHA) class III or ambulatory class IV HF symptoms despite maximally tolerated guideline directed medical therapy (GDMT) as assessed by a Cardiologist specialist in advanced heart failure (HF). All patients will have reduced left ventricular (LV) ejection fraction (EF) ≥ 20% and ≤ 50% and at least moderate to severe 3-4+ MR with a functional or combined functional and degenerative mechanism. Despite MitraClip treatment and maximum GDMT, these patients are at high risk for recurrent HF events and readmission, and thus there is an unmet need for further therapies to improve outcomes in this patient population.
The existing transseptal puncture used for MitraClip placement will be used to place the V-Wave Shunt device after MitraClip placement.
- Conditions
- Heart Failure, Mitral Regurgitation
- Being tested
- V-Wave Shunt Placement
- Medical subject headings
- Heart Failure, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-Wave Shunt PlacementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | V-Wave Shunt Placement Receives: Device: V-Wave Shunt Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE)
Number occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as:
- All cause death
- Stroke and paradoxical embolism
- Myocardial infarction
- V-Wave shunt device embolization
- Cardiac tamponade
- Device related re-intervention or surgery
Measured: Up to1 month post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start11 Mar 2021
- Primary completion3 Jan 2025
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- samir kapadia
- Sponsor type
- University, hospital or other
- Collaborators
- V-Wave Ltd
- Responsible party
- Sponsor-investigator, samir kapadia, The Cleveland Clinic
- Investigators
- Samir Kapadia, M. D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729933
- Sponsor's protocol ID
- G200329
- Other IDs
- IRB 21-068
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2021
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reed GW, Harmon EK, Harb S, Yun J, Krishnaswamy A, Abraham WT, Kapadia S. Design and Rationale of the V-Wave Shunt MitraClip Study. Am J Cardiol. 2024 Sep 15;227:29-36. doi: 10.1016/j.amjcard.2024.06.023. Epub 2024 Jun 29.
PubMed 38950689
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip: The V-Wave Shunt MitraClip Study
- ClinicalTrials.gov ID
- NCT04729933
- Acronym / sponsor ID
- G200329
- Conditions
- Heart Failure, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- samir kapadiaUniversity, hospital or other
- Collaborators
- V-Wave Ltd
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Posted 5 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The V-Wave Shunt is a device placed across the interatrial septum (IAS) by cardiac catheterization which allows for the transfer of blood from the left atrium (LA) to right atrium (RA). The intended effect is to reduce excessive left-sided cardiac filling pressures in patients with advanced heart failure (HF) and thus improve symptoms related to pulmonary congestion. All patients in the study must meet all anatomic and clinical eligibility in the FDA approved indications for use of the MitraClip in functional mitral regurgitation (MR). All patients must have persistence of New York Heart Association (NYHA) class III or ambulatory class IV HF symptoms despite maximally tolerated guideline directed medical therapy (GDMT) as assessed by a Cardiologist specialist in advanced heart failure (HF). All patients will have reduced left ventricular (LV) ejection fraction (EF) ≥ 20% and ≤ 50% and at least moderate to severe 3-4+ MR with a functional or combined functional and degenerative mechanism. Despite MitraClip treatment and maximum GDMT, these patients are at high risk for recurrent HF events and readmission, and thus there is an unmet need for further therapies to improve outcomes in this patient population.
The existing transseptal puncture used for MitraClip placement will be used to place the V-Wave Shunt device after MitraClip placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: V-Wave Shunt PlacementV-Wave Shunt Placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. 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).
- 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.
Key exclusion criteria (46 listed)
- Preliminary Exclusion Criteria (PEC) - to assessed by the Preliminary Screen at the baseline visit:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-Wave Shunt PlacementAfter the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device. | Device | Treatment |
Primary outcome
Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE)
Time frame: Up to1 month post implant
Number occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as: * All cause death * Stroke and paradoxical embolism * Myocardial infarction * V-Wave shunt device embolization * Cardiac tamponade * Device related re-intervention or surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38950689Reed GW, Harmon EK, Harb S, Yun J, Krishnaswamy A, Abraham WT, Kapadia S. Design and Rationale of the V-Wave Shunt MitraClip Study. Am J Cardiol. 2024 Sep 15;227:29-36. doi: 10.1016/j.amjcard.2024.06.023. Epub 2024 Jun 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Kapadia, M. D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-Wave Shunt Placement in people with Heart Failure and Mitral Regurgitation, run by samir kapadia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) (time frame: Up to1 month post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04729933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.