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

Sponsor

Medtronic Bakken Research Center (Industry)

Overall Status

Completed

CT.gov ID

NCT00170287

Collaborator

Medtronic (Industry)

116

Enrollment

Locations

Arms

111

Duration (Months)

16.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Substrate Modification Study in Patients Getting an ICD

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period [12 Months]

Secondary Outcome Measures

All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) [12 Months]
Quality of life [12 Months]
Number of hospital readmissions due to a cardiac indication [12 Months]
Severe clinical events [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Skejby Skygehus	Aarhus	Denmark	8200
2	Herz- und Gefäßklinik GmbH	Bad Neustadt / Saale	Germany	97616
3	Berufsgenossenschaftliche Kliniken Bergmannsheil	Bochum	Germany	44789
4	Klinikum der J.W. Goethe Universität	Frankfurt	Germany	60590
5	Allgemeines Krankenhaus St. Georg	Hamburg	Germany	20099
6	Universitätsklinikum Hamburg-Eppendorf	Hamburg	Germany	20251
7	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtronic Bakken Research Center

ClinicalTrials.gov Identifier:

NCT00170287

Other Study ID Numbers:

CEN_G_CA_3

First Posted:

Sep 15, 2005

Last Update Posted:

Sep 6, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Medtronic Bakken Research Center

Unstable Ventricular Tachycardia

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Ventricular

Study Results

No Results Posted as of Sep 6, 2017