Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia
|ClinicalTrials.gov Identifier: NCT01695551|
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : January 9, 2017
Ventricular tachycardia (VT) is a life-threatening, fast heart rhythm that starts in the lower chambers of the heart (the ventricles). This fast heartbeat is caused by abnormal electrical pathways located in the heart tissue. A standard procedure called a catheter ablation has been used for several years to help correct these abnormal pathways and, in some cases, improve or even eliminate the ventricular tachycardia.
During a VT ablation it is routine to monitor your vital signs (blood pressure, heart rate, and oxygen saturation in your blood). If you choose to participate in this study we will also monitor your cerebral oximetry, the amount of blood flow and oxygen saturation to your brain during the ablation.
By doing this study, we hope to have a better understanding of patients' blood and oxygen flow to their brain during an episode of Ventricular Tachycardia (VT).
|Condition or disease||Intervention/treatment|
|Ventricular Tachycardia||Other: Data Collection Forms|
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Assessment of Intracardiac and Surgace Electrogram Characteristics Correlated to Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
U.S. FDA Resources
Participants in cohort will have implantable defibrillators in-situ and are undergoing ablation procedure for ventricular tachycardia.
Other: Data Collection Forms
Participants will be asked questions relating to pre-procedure items and be asked to complete an MMSE. Subjects receive standard of care surgery. Data collected from procedures before, during and after surgery.
- Identify clinical, EKG and EGM characteristics of hemodynamically unstable VT [ Time Frame: Change from Baseline to 24-48 hours after surgery ]The investigator will be evaluating the relationship of the oxygenation level of the brain during a Ventricular Tachycardia ablation.
- MMSE to determine cerebral function before and after VT ablation [ Time Frame: 24 hours after surgery ]The use of the Mini-Mental Status Exam prior to the ablation will serve as a reference point and will be repeated 24 hours post exam.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695551
|United States, Kansas|
|University of Kansas Medical center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Dhanunjaya Lakkireddy, MD, FACC||University of Kansas Medical Center|