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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Ventricular Tachycardia

Being tested

Versed, Fentanyl, Propofol, Sevoflurane

Keywords

Ventricular tachycardia, ventricular tachycardia ablation, effects of anesthesia on VT induction, programed stimulation

Medical subject headings

Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• VersedDrug

  Also called midazolam

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

• FentanylDrug

  Also called Duragesic

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

• PropofolDrug

  Also called Diprivan

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

• SevofluraneDrug

  Also called Ultane

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

   Measured: While under General Anesthesia, an average of 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Apr 2015 (estimated)
2. Study startJul 2014
3. Primary completion26 Apr 2015
4. Study completion26 Apr 2015

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
• More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.