Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia

September 20, 2019 updated by: Douglas Shook, Brigham and Women's Hospital

Inducibility and Stability of Ventricular Tachycardia in Patients With Structural Heart Disease Undergoing VT Ablation Under General Anesthesia (Pilot Study)

This research study is being done to see whether general anesthesia (GA) affects our ability to start ventricular tachycardia (VT) during an VT ablation procedure.

Data collected during this research study will help electrophysiologists and anesthesiologists to make the best decisions about the best anesthetic conditions to use to perform VT ablations.

This research study is a "pilot" study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigahm and Women's Hospital

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with VT and have an implanted ICD who are scheduled for VT catheter ablation.
  • Patients 18 years of age or older

Exclusion Criteria:

  • Patients with difficult airway management or patients with contra/ relative contra indication for general anesthesia or known allergies to any of the proposed anesthetic agents
  • Women who are pregnant

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anesthesia Induction
Patients undergoing ventricular tachycardia ablation will undergo programmed stimulation (PS) with minimal sedation (Versed, Fentanyl), with intravenous agents (propofol) , and finally with volatile inhalational agent (sevoflurane).
Drug: Versed
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
Other Names:
  • midazolam
Drug: Fentanyl
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
Other Names:
  • Duragesic
Drug: Propofol
Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia
Other Names:
  • Diprivan
Drug: Sevoflurane
Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia
Other Names:
  • Ultane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.
Time Frame: While under General Anesthesia, an average of 6 hours
Patients before induction of GA undergo noninvasive programmed stimulation (NIPS) using the patient's ICD. Subjects receive minimal versed/fentanyl during the NIPS. The anesthesiologist will decide whether to use propofol prior to the second induction, depending on the patient's cardiac function and hemodynamic status. After induction of GA with IV propofol, programmed stimulation will be performed from the RV catheter. Mapping under volatile agent will commence any time after twice the redistribution half-life of either agent has elapsed (propofol 4-16 mins) or have passed. Once the drug is out of the central compartment it is unlikely to affect myocardial electrolytes or ion channels. GA will be maintained with an inhalation agent, sevoflurane. A repeat programmed stimulation test will be performed. Endpoint for programmed stimulation will be induction of sustained monomorphic VT (SMVT).
While under General Anesthesia, an average of 6 hours

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Wendy L Gross, M.D., Brigham and Women's Hospital

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, 2014

Primary Completion (Actual)

April 26, 2015

Study Completion (Actual)

April 26, 2015

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-P-000241

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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