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

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).

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection Forms

Other

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Dhanunjaya Lakkireddy, MD, FACC

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Sep 28, 2012
Registry last updated: Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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