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Displaying 1 - 11 of 11

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). (MITRAL-II)

Condition: Valve Disease / Mitral Valve Disease
Investigator: Isaac George, MD
Status: Currently Recruiting
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to…
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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial in Patients with Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
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MitraClip REPAIR MR Study in Patients with Primary Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
This is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial,…
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Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial (Fetus diagnosed with a fast heart rate)

Condition: Pediatrics / Cardiology
Investigator: Stephanie Levasseur, MD
Status: Closed
Although supraventricular tachycardia (SVT), including atrial flutter (AF), are the most common causes of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled clinical trial (RCT). In the absence of such evidence, there is no consensus for the optimal…
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Study of The Medtronic Intrepid Transcatheter Mitral Valve Replacement System in Patients with Severe, Symptomatic Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
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PARTNER 3 Trial: Mitral Valve in Valve

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is assessing the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
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Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment…
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Improvement of exercise capacity in patients with Fontan physiology

Condition: Pediatrics / Cardiology
Investigator: Marc Richmond, MD
Status: Closed
Over time, children and young adults who have had a Fontan operation may find they are more tired, have difficulty breathing and cannot exercise as well as before. Currently, there are no approved medicines to prevent this decline. The purpose of this research study is to learn whether children who have had the Fontan operation can improve their ability to…
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The CorCinch-HFrEF Study in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This trial is a non-randomized, prospective, multi-center early feasibility study to evaluate the safety and performance of the AccuCinch system in patients with Heart Failure and Reduced Ejection Fraction HFrEF
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Edwards Cardioband System & medical therapy versus medical therapy alone in patients with functional mitral regurgitation and heart failure

Condition: Valve Disease / Mitral Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE) (Pediatric)

Condition: Pediatrics / Cardiology
Investigator: Irene Lytrivi, MD
Status: Closed
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learnmore about which anti-rejection (or immunosuppressive) medications best protect infants, children,adolescents, and young adults after they have had a heart transplant. Two different drug regimens will bewill be compared. All of these drugs are FDA-…
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