Back to resultsInducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia
Primary Purpose
Ventricular Tachycardia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Versed
Fentanyl
Propofol
Sevoflurane
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventricular Tachycardia focused on measuring Ventricular tachycardia, ventricular tachycardia ablation, effects of anesthesia on VT induction, programed stimulation
Eligibility Criteria
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
Sites / Locations
- Brigahm and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Anesthesia Induction
Arm Description
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).
Outcomes
Primary Outcome Measures
Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02419547
First Posted
September 10, 2014
Last Updated
September 20, 2019
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02419547
Brief Title
Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia
Official Title
Inducibility and Stability of Ventricular Tachycardia in Patients With Structural Heart Disease Undergoing VT Ablation Under General Anesthesia (Pilot Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 26, 2015 (Actual)
Study Completion Date
April 26, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular tachycardia, ventricular tachycardia ablation, effects of anesthesia on VT induction, programed stimulation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anesthesia Induction
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Versed
Other Intervention Name(s)
midazolam
Intervention Description
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Duragesic
Intervention Description
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Ultane
Intervention Description
Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia
Primary Outcome Measure Information:
Title
Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.
Description
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).
Time Frame
While under General Anesthesia, an average of 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy L Gross, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigahm and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia
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