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NCT ID: NCT03228381 Recruiting - Heart Failure Clinical Trials

The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)

BOSS
Start date: August 21, 2017
Phase: N/A
Study type: Interventional

The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.

NCT ID: NCT02880683 Completed - Cardiac Output, Low Clinical Trials

Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study

COAST-HF HNrCS
Start date: October 2015
Phase: N/A
Study type: Interventional

A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

NCT ID: NCT02795676 Recruiting - Fabry Disease Clinical Trials

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function

BALANCE
Start date: June 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients treated for approximately 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then randomized to continue treatment with 1mg/kg agalsidase beta or to treatment with 1 mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator. Patients will receive intravenous infusions every two weeks. Patients will be randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample. No more than 50% of the patients will be female.

NCT ID: NCT02670460 Completed - Clinical trials for Ventilator Induced Lung Injury

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial

Start date: October 2015
Phase: N/A
Study type: Interventional

Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.

NCT ID: NCT02607527 Recruiting - Clinical trials for Mitral Valve Insufficiency

Annular Reshaping of the Mitral Valve for MR Using the Millipede IRIS System

Start date: January 2017
Phase: N/A
Study type: Interventional

Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

NCT ID: NCT02278913 Completed - Diabetes Clinical Trials

Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay

Start date: April 2009
Phase: Phase 4
Study type: Interventional

Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen with analogs and human insulins in general medicine patients admitted to a University Hospital in Asuncion, Paraguay.

NCT ID: NCT02268045 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma

Start date: May 2013
Phase: Phase 3
Study type: Interventional

Study of RTXM83 plus CHOP chemotherapy versus a rituximab plus CHOP therapy in patients with Non Hodgkin's lymphoma The primary endpoint of the investigation is to determine if the response rate obtained with RXM83 combined with CHOP is non inferior to the response rate obtained with reference rituximab combined with CHOP The present study is a non inferiority trial and the study hypothesis is the following: H0: pc ≥ pe + δ vs. H1: pc < pe + δ where, pe: proportion of successes in the experimental group (RTXM83+CHOP) pc: proportion of successes in the control group (Reference Rituximab+CHOP) Type I error: the difference pc-pe is less than δ when in fact the difference is greater than or equal to δ ie, the investigators choose the experimental treatment when the control treatment is actually substantially better. Type II error: the difference -pe is greater than or equal to δ when it is actually lest than δ ie, the investigators choose the control treatment when the experimental treatment is essentially just as good.

NCT ID: NCT02156609 Completed - Clinical trials for High Risk Percutaneous Coronary Intervention

HeartMate PHP™ CE Mark Clinical Investigation Plan

HM PHP CE Mark
Start date: June 2014
Phase: N/A
Study type: Interventional

The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.

NCT ID: NCT02119845 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

Start date: August 2012
Phase: N/A
Study type: Interventional

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.

NCT ID: NCT02119832 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)

Start date: April 2013
Phase: N/A
Study type: Interventional

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.