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

NCT01695551 | Completed

• 1 other identifier: 13054
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ventricular Tachycardia

Keywords

Radiofrequency ablation; fast heart rhythm; ventricle; catheter ablation; ablation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• MMSE to determine cerebral function before and after VT ablation

  24 hours after surgery

Study Arms (1)

Ventricular Tachycardia

Participants in cohort will have implantable defibrillators in-situ and are undergoing ablation procedure for ventricular tachycardia.

Other: Data Collection Forms

Interventions

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.

Ventricular Tachycardia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Able to give informed consent
• Have implantable defibrillator in-situ and are undergoing ablation procedure for ventricular tachycardia

You may not qualify if:

• 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

Sponsors & Collaborators

• Dhanunjaya Lakkireddy, MD, FACC: lead

Study Sites (1)

University of Kansas Medical center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Study Officials

• Dhanunjaya Lakkireddy, MD, FACC

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: September 28, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (1)