203 studies found for:    u.s. pivotal trial
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Rank Status Study
1 Recruiting Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Condition: Severe Aortic Stenosis
Interventions: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI);   Device: Surgical Aortic Valve Replacement (SAVR)
2 Active, not recruiting Esteem Totally Implantable Hearing System
Condition: Mild to Severe Sensorineural Hearing Loss
Intervention: Device: Esteem-Totally Implantable Hearing System
3 Active, not recruiting Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
Condition: Skin Diseases
Intervention:
4 Active, not recruiting Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
Condition: Coronary Artery Disease
Intervention: Device: Diamondback 360 Orbital Atherecotmy System
5 Recruiting CVRx Barostim Hypertension Pivotal Trial
Condition: Uncontrolled Hypertension
Intervention: Device: Neo Baroreflex Activation Therapy System
6 Recruiting Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Very High Risk Subjects Who Need Aortic Valve Replacement
Condition: Severe Aortic Stenosis
Intervention: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
7 Active, not recruiting Rheos® Pivotal Trial
Condition: Hypertension
Intervention: Device: Rheos® Baroreflex Hypertension System
8 Unknown  VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
Conditions: End-stage Heart Failure;   Cardiomyopathies
Intervention: Device: VentrAssistTM Left Ventricular Assist Device
9 Recruiting International EXPAND Lung Pivotal Trial
Condition: Lung Transplant
Intervention: Device: OCS Lung Preservation
10 Completed
Has Results
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Condition: Venous Leg Ulcer
Interventions: Device: Dermagraft(R);   Device: Profore
11 Recruiting Respicardia, Inc. Pivotal Trial of the remedē System
Conditions: Sleep Apnea, Central;   Sleep Disordered Breathing;   Heart Failure
Interventions: Device: Treatment Group (remede; phrenic nerve stimulation);   Device: Control Group (Optimal Medical Therapy)
12 Completed Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Condition: Venous Leg Ulcer
Interventions: Device: Dermagraft;   Device: Profore
13 Completed A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
Condition: Metastatic Melanoma
Interventions: Biological: Allovectin-7®;   Drug: Dacarbazine (DTIC);   Drug: Temozolomide (TMZ)
14 Recruiting A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
Conditions: Congestive Heart Failure;   Left Ventricular (LV) Systolic Dysfunction
Intervention: Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
15 Not yet recruiting REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT
Conditions: Renal Cell Carcinoma;   Kidney Cancer
Intervention: Drug: Iodine (124I) Girentuximab
16 Active, not recruiting A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
Condition: Obesity
Interventions: Device: ReShape Duo balloon;   Other: Diet & exercise counseling
17 Terminated Contrast Media Reduction and Removal in Patients With CKD (PRESERV)
Condition: Contrast Induced Nephropathy
Interventions: Device: CINCOR™ System;   Drug: Peri-procedural hydration
18 Recruiting Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
Condition: Brain Aneurysm
Intervention: Device: Surpass Flow Diverter
19 Completed
Has Results
Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
Condition: Candidiasis
Interventions: Drug: fluconazole;   Drug: placebo
20 Completed Evaluation of the Ulthera System for the Treatment of the Decolletage
Condition: Chest Wrinkles
Intervention: Device: Ulthera System Treatment

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Indicates status has not been verified in more than two years