Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following M… (NCT04729933) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip
United States16 participantsStarted 2021-03-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines a MitraClip procedure with implanting a permanent interatrial shunt — can you explain what both of those devices do and why using them together might benefit someone with my type of heart failure and mitral regurgitation?
2The trial is no longer enrolling new participants but is still active — does that mean the main thing happening now is monitoring existing patients for serious heart and neurological events, and what would the results of that monitoring tell us about safety?
3Since this study isn't assigned a traditional phase like Phase 1 or 2, what does that mean for how much is already known about the risks of this shunt device, and how does that compare to what's established for MitraClip alone?
4The trial's primary measure is tracking major adverse cardiovascular and neurological events — if my doctor has access to any early data or findings so far, what signals, if any, have emerged about those kinds of serious complications?
5Before considering a study like this, should we talk about whether standard MitraClip treatment alone — without the additional shunt implant — might be a safer or more proven first step for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE)
. 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.
. Flail width \<15 mm
Exclusion criteria
. 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.