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Completed

NCT Number: NCT02419547

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigahm and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Versed

Drug

Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia

Other names: midazolam

Fentanyl

Drug

Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia

Other names: Duragesic

Propofol

Drug

Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia

Other names: Diprivan

Sevoflurane

Drug

Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia

Other names: Ultane

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2015
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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