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Displaying 1 - 10 of 10

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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A Study of the Gene Therapy CGF166 in Patients with Severe-to-Profound Hearing Loss

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Lawrence Lustig, MD
Status: Closed
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…
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A Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the TULA Iontophoresis and Tube Delivery Systems

Condition: Ear, Nose and Throat
Investigator: Eli Grunstein, MD
Status: Closed
The objective of the study is to evaluate the safety and effectiveness of the TULA System for the placement of tympanostomy tubes (ear tubes) under local anesthesia in an office/clinic setting.
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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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A Study To Assess The Efficacy And Safety Of 2 Dose Regimens Or Orally Administered SENS-111

Condition: Ear, Nose and Throat
Investigator: Ana Kim, MD
Status: Closed
Acute unilateral vestibulopathy (AUV) (previously called acute vestibular neuritis) is the third most frequent cause of peripheral vestibular vertigo, after benign paroxysmal positional vertigo and Menires disease.The goal of this study is to look at the effects of a new drug (SENS-111) in controlling the acute vertigo and other symptoms related to AUV more…
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A study to Assess Safety and Effectiveness of Study Drug OTO-104 in Patients at Risk of Hearing Loss From Cisplatin Chemotherapy

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Alice Lee, MD
Status: Closed
Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an…
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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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A study for Adults with Sudden Sensorineural Hearing Loss Using the drug Am-111 to Evaluate its Effectiveness in Restoring Hearing Loss

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Anil Lalwani, MD
Status: Closed
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
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