NCT00919373

Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy

Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to compare the time from randomization to the first recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and patients not undergoing ablation, with both groups under the protection of an ICD.

Detailed description

The main objective of this study is to compare the time from randomization to the first recurrence of any VT in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and patients not undergoing ablation, with both groups under the protection of an ICD. Prior to the ablation, the patients will undergo electrophysiologic study (EPS) with programmed ventricular stimulation, with the aim to reproduce the clinical VT. Most patients with coronary artery disease, systolic LV dysfunction, and one episode of clinical sustained VT have more than one inducible VT at electrophysiologic study. Since any inducible VT can become a potential clinical VT (24), an attempt will be made to ablate the clinical stable VT, as well as all inducible morphologies, stable or unstable. One of the following 2 ablation strategies will be possible for each VT: * Substrate modification in sinus rhythm in case of unstable induced monomorphic VT which does not allow mapping and ablation in tachycardia, or noninducible stable clinical VT. * VT ablation in tachycardia in case of stable VT For each procedure the number of tachycardias , the type of each tachycardia (inducible or noninducible, stable or unstable), the ablation strategy for each tachycardia (it is possible that lesions deployed for one tachycardia will render another tachycardia noninducible as well) and the procedural outcome for each tachycardia will be documented.

Conditions

• Ventricular Tachycardia
• Coronary Artery Disease
• Left Ventricular Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Substrate modification	Catheter Ablation procedure - Substrate modification in sinus rhythm in case of unstable induced monomorphic Ventricular Tachycardia (VT) which does not allow mapping and ablation in tachycardia, or noninducible stable clinical VT.
PROCEDURE	VT ablation	Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT
PROCEDURE	ICD Implantation	Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical

Timeline

• Start date: 2002-07-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2009-06-12
• Last updated: 2019-02-04

Locations

16 sites across 4 countries: Czechia, Denmark, Germany, Switzerland