Related Clinical Trials

Heart Catheterization using MRI Fluoroscopy and Passive Guidewires (NCT03152773)

Heart catheterization is a minimally invasive procedure to measure pressure into specific heart cavities.   Heart catheterization usually uses X-ray guidance, which involves radiation exposure, and which fails to visualize soft tissue.  For several years, real-time magnetic resonance imaging (MRI) fluoroscopy has been the standard technique to guide right heart catheterization at the NIH clinical center.

Guidewires are standard tools used to steer catheters through the body and heart.  Guidewires have not been used during MRI fluoroscopy catheterization because of the risk of heating.  We have developed MRI techniques that do not risk heating using specific commercial guidewires.  In this protocol we will use this new “low-energy” real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins, and of the left side of the heart through the aorta.

NHLBI DIR LAMPOON Study (NCT03015194)

Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist.  In as many as half of patients, TMVR can cause life-threatening blockage of the left ventricle by displacing the existing mitral valve leaflet. For these patient’s the only options appear to avoid TMVR or in some to cause a focused heart attack and to wait 6 weeks.  The investigators have developed and tested a technique to tear the existing mitral valve leaflet and enable TMVR in patients who have no other options. The procedure is called intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON).  Although there are no dedicated TMVR devices commercially available, there has been short-term success with implanted transcatheter aortic valve devices in the mitral position for TMVR.

The purpose of this study is to perform LAMPOON and TMVR in patients who have no good options to treat their mitral valve failure, using heart valve devices designed to implant in the aortic valve position.

Transmural Systems Transcaval Closure Device (NCT03432494)

Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) enables transcathe-ter aortic valve replacement (TAVR) in patients not eligible for femoral artery access. Currently the proce-dure is performed using devices, off-label, designed and marketed to close holes inside the heart and great vessels, manufactured by Abbott St Jude (Amplatzer Duct Occluder and Amplatzer Muscular VSD Occluder).  Because these Amplatzer occluders are not designed to close transcaval access sites, they may not com-pletely prevent bleeding. 

This is an early feasibility study (EFS) evaluation of a purpose-built closure device for transcaval access.  The device, the Transcaval closure device (TCD) will be evaluated for safety and performance to close transcaval access sites in patients ineligible for femoral artery access for TAVR.

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study (NCT03929913)

This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation, called transcatheter mitral valve cerclage annuloplasty, otherwise known as “cerclage.”

Functional mitral valve regurgitation is a condition caused by damaged heart muscle involving the left ventricle which results in mitral valve leakage.

This leakage causes heart failure (breathlessness and lack of energy especially when walking or exercising, and hospital admissions for fluid buildup). This is an early feasibility study (EFS) evaluation of special devices, permanently implanted in the heart, to perform mitral cerclage annuloplasty. Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery. The cerclage devices compress the mitral valve like a purse-string. The cerclage device has a special feature that prevents a coronary artery from getting squeezed as part of this purse-string.

The protocol has been changed to allow patients who have mitral valve regurgitation despite prior Mitra-Clip treatment. The protocol has been changed to allow patients who have symptomatic heart failure and mild mitral regurgitation.

TransAtrial IntraPericardial Tricuspid Annuloplasty (Pending)

Functional tricuspid valve regurgitation is common, has high morbidity and mortality, and has no good treatments. We developed a new transcatheter treatment for this orphan disease called TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty). In TRAIPTA, catheter tools cross the wall of the heart to enter the pericardial space surrounding the heart, encircle the heart around the atrioventricular groove, and apply tension to reshape and narrow the heart to help the leaky tricuspid valve to function better. After placing the belt, a closure device is deployed to close the puncture in the right atrial appendage.

This is the first human test of the TRAIPTA technique. It is offered to patients who are suffering from clinically significant tricuspid valve regurgitation and who have no other good treatment options.