Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

Official title:

Assessment of Intracardiac and Surgace Electrogram Characteristics Correlated to Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695551
• Other study ID #: 13054
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: January 5, 2017
• Start date: July 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to give informed consent

• Have implantable defibrillator in-situ and are undergoing ablation procedure for ventricular tachycardia

Exclusion Criteria:

• Patients who have been hypotensive with systolic blood pressure of < 80mm Hg prior to procedure

• Cerebral event as defined by Cerebrovascular Accident or Transient Ischemia Attack within six months prior to procedure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Dhanunjaya Lakkireddy, MD, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify clinical, EKG and EGM characteristics of hemodynamically unstable VT	The investigator will be evaluating the relationship of the oxygenation level of the brain during a Ventricular Tachycardia ablation.	Change from Baseline to 24-48 hours after surgery	No
Secondary	MMSE to determine cerebral function before and after VT ablation	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.	24 hours after surgery	No