Research
Clinical trials are a set of procedures in medical research conducted to test the safety and effectiveness of drugs, medical devices, therapy protocols and diagnostics, and they are the basis for new treatments for any particular disease.
Clinical trials involve volunteer patients with a specific health condition and a group of healthy volunteers (control group). Volunteer patients may benefit with treatments that are otherwise unavailable.
Clinical trials must be approved by the Institutional Review Board (IRB) which is a supervising ethics committee, which grants permission to run the trial. The IRB ensures that participating patients are well informed about the nature of the trial and that a fully informed consent is obtained before participation.
Englewood Cardiac Surgery is currently participating in the following study:
(Information obtained from ClinicalTrails.gov)
Medtronic Concomitant Utilization of Radiofrequency for Atrial Fibrillation CURE-AF/Persistent (CURE-AF/Perst)
Sponsor: Medtronic Cardiac Surgery
ClinicalTrials.gov Identifier: NCT00506493
This study is ongoing, but not recruiting participants
Purpose:
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat persistent AF patients.
Condition |
Intervention |
Phase |
Atrial Fibrillation |
Device: Surgical RF Ablation utilizing the Cardioblate System |
Phase III |
Study Type: Interventional
Study Design:
Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation CURE-AF/Persistent (CURE-AF/Perst)
Principal Investigator: James Klein, MD
Englewood Hospital & Medical Center, 350 Engle Street, Englewood, NJ 07301
For additional information, please visit http://clinicaltrials.gov/show/NCT00506493
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