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

January 5, 2017 updated by: Dhanunjaya Lakkireddy, MD, FACC

Assessment of Intracardiac and Surgace Electrogram Characteristics Correlated to 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from those that visit University of Kansas Medical Center Cardiology clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ventricular Tachycardia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to 24-48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dhanunjaya Lakkireddy, MD, FACC

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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