Clinical Trials Logo

Filter by:
NCT ID: NCT01058980 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

ADenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination: the ADVICE Trial

ADVICE
Start date: December 2009
Phase: Phase 4
Study type: Interventional

Atrial fibrillation (AF) is the most common heart rhythm disorder, impairs quality of life and increases stroke risk and mortality. Despite advances in medical treatment, AF remains uncontrolled in many patients. In many patients, AF is initiated by abnormal electrical impulses from the pulmonary veins. A catheter ablation procedure called pulmonary vein isolation (PVI) has therefore been developed, using heat to isolate the PV foci from the heart. PVI is very effective, but must be repeated in up to 50% of cases because the foci isolation is not permanent after initial PVI. The intravenous administration of a drug called adenosine during the PVI procedure can unmask residual conduction that would otherwise remain unnoticed, so-called "dormant conduction". In our experience, additional ablation guided by adenosine reduces AF recurrence and the need for a repeat PVI procedure. However, the adenosine-guided approach has not yet been proven as standard therapy. The present study, to be conducted at 15 clinical centres in Canada, Europe and Australia is therefore intended to evaluate the efficacy of adenosine-guided ablation to prevent AF recurrence. Five hundred twenty-six patients will be included in the study, which should be completed within 2 years. In all patients, the presence of dormant conduction will be tested with adenosine during PVI. If dormant conduction is observed, additional ablation will be performed in half of these patients selected randomly. If there is no dormant conduction, randomly selected patients will be followed in a registry. If the adenosine-guided approach is demonstrated to improve the success rate of PVI procedures, it should become the standard approach for a "permanent cure" of AF, and therefore benefit patients by reducing arrhythmia recurrence, hospitalizations and the need for repeat interventions.

NCT ID: NCT01058174 Completed - Clinical trials for Liver Transplantation

Liver Transplant European Study Into the Prevention of Fungal Infection

TENPIN
Start date: December 15, 2009
Phase: Phase 3
Study type: Interventional

Prevention of invasive fungal infection in high risk patients following liver transplant.

NCT ID: NCT01057329 Completed - Depression Clinical Trials

Therapeutic Drug Monitoring in Child and Adolescent Psychiatry

TDMKJP
Start date: January 2010
Phase:
Study type: Observational

The investigators aim to analyse in adolescents with mental illness effectiveness, side effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole), antidepressants (Duloxetine, Atomoxetine) by means of "Therapeutic Drug Monitoring" (TDM) in order to optimize dosage - effect relations and minimize unwanted side effects.

NCT ID: NCT01056250 Completed - Cholecystolithiasis Clinical Trials

SILS Cholecystectomy: Cholangiography of the Biliary Tract

Start date: September 2009
Phase: N/A
Study type: Interventional

Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.

NCT ID: NCT01056120 Completed - Clinical trials for De Novo and Re-stenosed Coronary Artery Lesions

Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

ENERGY
Start date: March 2010
Phase: N/A
Study type: Observational

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

NCT ID: NCT01055951 Completed - Type 1 Diabetes Clinical Trials

Feasibility Study of the Solo™ Insulin Pump

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and usability of the Solo™ insulin MicroPump in subjects with type 1 diabetes who are pump users.

NCT ID: NCT01053715 Completed - Hemophilia A Clinical Trials

Quality of Life Study of Helixate NexGen

Start date: January 2010
Phase: N/A
Study type: Observational

The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.

NCT ID: NCT01052519 Completed - Obesity Clinical Trials

Obesity and Goal-directed Intraoperative Fluid Therapy

Start date: January 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to compare non-obese patients (BMI≤ 30 kg/m2)versus obese patients (BMI> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery. Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (PsqO2)is increased in obese patients when fluid management is optimized by means of esophageal Doppler monitoring compared to obese patients undergoing standard fluid management. Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. Thus the investigators assume that PsqO2 is similar in obese and non-obese patients when fluid management is optimized in both groups.

NCT ID: NCT01051258 Completed - Lung Diseases Clinical Trials

AeriSeal System for Lung Volume Reduction

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

NCT ID: NCT01045707 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

BOOST™
Start date: January 2010
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug). The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.