Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation Save

Date Added
February 13th, 2018
PRO Number
Pro00072452
Researcher
Jeffrey Winterfield

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Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to collect information on the safety of the TactiCath SE ablation catheter when it is used to treat atrial fibrillation.This study will collect information about the success of the procedure and report on the number and type of follow-up problems that may occur during or after the ablation procedure (sometimes called adverse events). Data collected for this study will be submitted for review and approval by the FDA.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Safety and Efficacy of Periprocedural Apixaban Use for Reduction of the Risk of Cerebrovascular Events in Patients Undergoing Ventricular Tachycardia Radiofrequency Catheter Ablation Save

Date Added
December 12th, 2017
PRO Number
Pro00070088
Researcher
Jeffrey Winterfield

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Keywords
Cardiovascular
Summary

The purpose of this study is to learn if taking a drug called apixaban, given orally, before and after an ablation procedure keeps blood clots from forming and lowers the chance of having a stroke in VT (ventricular tachycardia) patients. Apixaban is a blood thinning drug, also called an anticoagulant. Apixaban is compared to Aspirin. Aspirin is mainly used to treat fever, pain and inflammatory conditions such as arthritis.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

VIVO™ Accuracy Protocol Save

Date Added
November 28th, 2017
PRO Number
Pro00072236
Researcher
Jeffrey Winterfield

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Keywords
Cardiovascular
Summary

VIVO is a non-FDA approved software product that uses a laptop computer and a handheld Kinect 3D camera. VIVO combines patient-specific images from either a CT scan or MRI of the torso and cardiac structures with a 3D image of the torso that identifies precise ECG lead placement to generate a 3D model of the patient's heart. The purpose of the study is to give the FDA more information about the accuracy and safety of VIVO. Information will be collected about the participant and the ablation procedure he/she is scheduled to have.The VIVO algorithm will be used to assess the accuracy of VIVO to create a patient- specific model, thus improving the accuracy of locating the irregular heartbeats during an ablation procedure.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2244
adamsde@musc.edu

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