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Displaying 1 - 9 of 9

Clinical Study of the Edwards Cardioband FIT Valve Repair System

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The Edwards Cardioband Tricuspid Valve Reconstruction FIT valve repair system is a prospective, single arm, multi-center study to evaluate the safety and performance of the Cardioband Tricuspid System. The Edwards Cardioband Tricuspid Valve Reconstruction System is intended for patients with tricuspid regurgitation deemed to be potential candidates for…
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Study of C2 CryoBalloon Focal Ablation System for Patients with Barrett's Esophagus

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Currently Recruiting
This research study will look at a newer treatment option for Barrett's Esophagus (BE) which uses nitrous oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA-cleared…
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CLASP II TR: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial in Patients with Tricuspid Regurgitation

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System's implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as…
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TTVR Early Feasibility Study in Patients with Symptomatic Severe Tricuspid Regurgitation - Medtronic

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Currently Recruiting
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood…
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TRISCEND ll PIVOTAL Study of the Edwards EVOQUE Tricuspid Valve Replacement System

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a prospective, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart…
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Study of the Evoque System in People with Tricuspid Regurgitation (TRISCEND Study)

Condition: Valve Disease / Tricuspid Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.…
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A study for patients with untreated dysplastic Barrett's Epithelium using the Coldplay CryoBallon Focal Ablation System

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
C2 Therapeutics is currently enrolling patients to participate in the Coldplay 3 clinical trial. Coldplay 3 is evaluating the effectiveness of the Coldplay CryoBalloon Focal Ablation System in patients with Barrett's esophagus who have not yet received treatment. Participants will undergo treatment with the Coldplay CryoBalloon Focal Ablation System…
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A study for patients with Barrett's esophagus using a Wide Area Transepithelial Sample Esophageal Biopsy (WATS) kits for analysis

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
The purpose of this study is to evaluate a new technique called Wide Area Transepithelial Sample 3-Dimensional Esophageal Biopsy (WATS) with computer assisted method of analysis of brush biopsy. This study will assess whether performing standard biopsies in addition to the WATS brush biopsies identifies more patients with dysplasia than does performing…
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Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN)

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Closed
The purpose of the study is to compare two types of endoscopic treatments in patients with Barretts esophagus (BE) with abnormal cells (dysplasia); radiofrequency ablation (RFA) and hybrid argon plasma coagulation (H-APC). H-APC is a newer technique in the treatment of BE and has not been adequately studied and is not approved by the FDA for routine use.…
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