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

Primary Purpose

Tachycardia, Ventricular

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ICD Ablation plus VT-ablation
ICD Therapy
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia, Ventricular focused on measuring Unstable Ventricular Tachycardia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skejby Skygehus
  • Herz- und Gefäßklinik GmbH
  • Berufsgenossenschaftliche Kliniken Bergmannsheil
  • Klinikum der J.W. Goethe Universität
  • Allgemeines Krankenhaus St. Georg
  • Universitätsklinikum Hamburg-Eppendorf
  • Klinikum der Stadt Ludwigshafen am Rhein

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

ICD Therapy plus VT-Ablation

ICD Therapy only

Outcomes

Primary Outcome Measures

Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period

Secondary Outcome Measures

All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)
Quality of life
Number of hospital readmissions due to a cardiac indication
Severe clinical events

Full Information

First Posted
September 9, 2005
Last Updated
September 5, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00170287
Brief Title
SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
Acronym
SMS
Official Title
Substrate Modification Study in Patients Getting an ICD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
Keywords
Unstable Ventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ICD Therapy plus VT-Ablation
Arm Title
2
Arm Type
Active Comparator
Arm Description
ICD Therapy only
Intervention Type
Procedure
Intervention Name(s)
ICD Ablation plus VT-ablation
Intervention Description
ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
Intervention Type
Device
Intervention Name(s)
ICD Therapy
Intervention Description
ICD Therapy for the Treatment of unstable VT´s
Primary Outcome Measure Information:
Title
Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)
Time Frame
12 Months
Title
Quality of life
Time Frame
12 Months
Title
Number of hospital readmissions due to a cardiac indication
Time Frame
12 Months
Title
Severe clinical events
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, MD
Organizational Affiliation
Allgemeines Krankenhaus St. Georg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skejby Skygehus
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Herz- und Gefäßklinik GmbH
City
Bad Neustadt / Saale
ZIP/Postal Code
97616
Country
Germany
Facility Name
Berufsgenossenschaftliche Kliniken Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Allgemeines Krankenhaus St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28292751
Citation
Kuck KH, Tilz RR, Deneke T, Hoffmann BA, Ventura R, Hansen PS, Zarse M, Hohnloser SH, Kautzner J, Willems S; SMS Investigators. Impact of Substrate Modification by Catheter Ablation on Implantable Cardioverter-Defibrillator Interventions in Patients With Unstable Ventricular Arrhythmias and Coronary Artery Disease: Results From the Multicenter Randomized Controlled SMS (Substrate Modification Study). Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004422. doi: 10.1161/CIRCEP.116.004422.
Results Reference
derived

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

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