Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01901575
Other study ID # 11-00800
Secondary ID
Status Completed
Phase Phase 4
First received April 16, 2013
Last updated December 7, 2017
Start date July 2011
Est. completion date April 2013

Study information

Verified date December 2017
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin


Description:

The purpose of the study is to determine the effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Remifentanil is an analgesic- synthetic opiate with an very short half life. It is rapidly broken down by enzymes in the blood and is ideally suited for continuous sedation. The effect is practically eliminated within 5 minutes after the intravenous sedation is stopped.

You are being asked to participate in this study because you are already scheduled to undergo EP studies under the care of your cardiologist for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients scheduled to undergo EP studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin

- Patients between 18 and 65

- ASA 1-3

Exclusion Criteria:

- ASA 4 and 5

- Age 18 and 65

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remifentanil
Patients with established PVC's , sedated with remifentanil IVPCA per study protocol

Locations

Country Name City State
United States NYU Langone Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Garofalo NA, Teixeira-Neto FJ, Schwartz DS, Vailati Mdo C, Steagall PV. Effects of the opioid remifentanil on the arrhythmogenicity of epinephrine in halothane-anesthetized dogs. Can J Vet Res. 2008 Jul;72(4):362-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Inhibition of Idiopathic Ventricular Tachycardia observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's.
Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation.
duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours
Primary PVC Suppression With Remifentanil Sedation 1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression duration of the operative procedure, average 2 hours
See also
  Status Clinical Trial Phase
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT04070300 - Physical Activity and Ventricular Arrhythmias N/A
Completed NCT04075253 - Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia N/A
Completed NCT00000531 - Antiarrhythmics Versus Implantable Defibrillators (AVID) Phase 3
Completed NCT00000480 - Multicenter Unsustained Tachycardia Trial (MUSTT) Phase 3
Completed NCT05086510 - Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping N/A
Completed NCT01940081 - The Leiden Nonischemic Cardiomyopathy Study
Recruiting NCT01222156 - Accuracy and Safety Study of the Magnetecs CGCI System for Intracardiac Mapping Phase 1/Phase 2
Terminated NCT00749671 - Bispectral Index Monitoring During Testing in the Electrophysiology Lab N/A
Recruiting NCT00385749 - Right Ventricular Defibrillation Lead Select Site Study N/A
Completed NCT00382928 - Automatic External Defibrillation Monitoring in Cardiac Arrest Phase 1
Completed NCT00279279 - PREPARE - Primary Prevention Parameters Evaluation N/A
Terminated NCT00776087 - European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco) N/A
Withdrawn NCT00510731 - The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events N/A
Completed NCT01572246 - Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators N/A
Completed NCT00170287 - SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD) Phase 4
Completed NCT00147277 - ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy Phase 4
Completed NCT00004559 - Fatty Acid Antiarrhythmia Trial (FAAT) Phase 3
Completed NCT00702117 - Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias Phase 4
Completed NCT00232297 - Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS Phase 2