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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419547
• Other study ID #: 2013-P-000241
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: April 26, 2015

Study information

• Verified date: September 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 26, 2015
• Est. primary completion date: April 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Drug:
• Versed
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
• Fentanyl
Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
• Propofol
Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia
• Sevoflurane
Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia

Locations

Country	Name	City	State
United States	Brigahm and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	While under General Anesthesia, an average of 6 hours