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

NCT00170287 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-07-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Karl-Heinz Kuck, MD · Allgemeines Krankenhaus St. Georg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2010-04-30
Completion
2011-08-31

Countries

  • Denmark
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00170287 on ClinicalTrials.gov