NCT00170287

SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)

Substrate Modification Study in Patients Getting an ICD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions. The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.

Conditions

• Tachycardia, Ventricular

Interventions

Type	Name	Description
PROCEDURE	ICD Ablation plus VT-ablation	ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
DEVICE	ICD Therapy	ICD Therapy for the Treatment of unstable VT´s

Timeline

• Start date: 2002-05-01
• Primary completion: 2010-04-01
• Completion: 2011-08-01
• First posted: 2005-09-15
• Last updated: 2025-07-03

Locations

7 sites across 2 countries: Denmark, Germany