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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01695551
First received: July 5, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 Intervention
Ventricular Tachycardia
Other: Data Collection Forms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Intracardiac and Surgace Electrogram Characteristics Correlated to Brain Perfusion and Hemodynamic Stability in Patients Undergoing Radiofrequency Ablation of Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Identify clinical, EKG and EGM characteristics of hemodynamically unstable VT [ Time Frame: Change from Baseline to 24-48 hours after surgery ] [ Designated as safety issue: No ]
    The investigator will be evaluating the relationship of the oxygenation level of the brain during a Ventricular Tachycardia ablation.


Secondary Outcome Measures:
  • MMSE to determine cerebral function before and after VT ablation [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695551

Locations
United States, Kansas
University of Kansas Medical center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC University of Kansas
  More Information

No publications provided

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01695551     History of Changes
Other Study ID Numbers: 13054
Study First Received: July 5, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Radiofrequency ablation
fast heart rhythm
ventricle
catheter ablation
ablation

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014