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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00170287
First received: September 9, 2005
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Tachycardia, Ventricular
Procedure: ICD Ablation plus VT-ablation
Device: ICD Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Substrate Modification Study in Patients Getting an ICD

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Number of hospital readmissions due to a cardiac indication [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Severe clinical events [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: May 2002
Study Completion Date: August 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ICD Therapy plus VT-Ablation
Procedure: ICD Ablation plus VT-ablation
ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
Active Comparator: 2
ICD Therapy only
Device: ICD Therapy
ICD Therapy for the Treatment of unstable VT´s

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery disease documented by coronary angiography. For the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure.
  • Left ventricular ejection fraction < 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days.
  • Clinical unstable VT without reversible factors (acute ischemia or antiarrhythmic medications as defined below). Unstable VT can have one of the following clinical presentations:

    • Hypotensive VT without major neurologic dysfunction;
    • Syncope; or
    • Cardiac arrest.

Exclusion Criteria:

  • Age < 18 years or > 80 years
  • Protruding left ventricular (LV) thrombus on pre-ablation echocardiogram
  • Acute myocardial infarction within the preceding 2 months
  • Class IV New York Heart Association (NYHA) heart failure
  • Valvular heart disease or mechanical heart valve precluding access to the left ventricle
  • Unstable angina
  • Cardiac surgery within the past 2 months
  • Serum creatinine > 220 mmol/L (2.5 mg/dL)
  • Thrombocytopenia or coagulopathy
  • Contraindication to heparin
  • Pregnancy
  • Acute illness or active systemic infection
  • Other disease process likely to limit survival to less than 12 months
  • Significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study
  • Participation in another investigational study
  • Unwillingness to participate or lack of availability for follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170287

Locations
Denmark
Skejby Skygehus
Aarhus, Denmark, 8200
Germany
Herz- und Gefäßklinik GmbH
Bad Neustadt / Saale, Germany, 97616
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany, 44789
Klinikum der J.W. Goethe Universität
Frankfurt, Germany, 60590
Allgemeines Krankenhaus St. Georg
Hamburg, Germany, 20099
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, Germany, 67063
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Principal Investigator: Karl-Heinz Kuck, MD Allgemeines Krankenhaus St. Georg
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00170287     History of Changes
Other Study ID Numbers: CEN_G_CA_3
Study First Received: September 9, 2005
Last Updated: January 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
Unstable Ventricular Tachycardia

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014