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| Sponsor: | St. Jude Medical |
|---|---|
| Information provided by: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00919373 |
Purpose
The main objective of this study is to compare the time from randomization to the first recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and patients not undergoing ablation, with both groups under the protection of an ICD.
| Condition | Intervention |
|---|---|
|
Ventricular Tachycardia Coronary Artery Disease Left Ventricular Dysfunction |
Procedure: Substrate modification Procedure: VT ablation Procedure: ICD Implantation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy |
| Enrollment: | 110 |
| Study Start Date: | July 2002 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ICD-Implantation
Implantation of an Implantable Cardioverter Defibrillator (ICD) alone.
|
Procedure: ICD Implantation
Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical
|
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Active Comparator: ICD + Ablation
Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation
|
Procedure: Substrate modification
Catheter Ablation procedure - Substrate modification in sinus rhythm in case of unstable induced monomorphic Ventricular Tachycardia (VT) which does not allow mapping and ablation in tachycardia, or noninducible stable clinical VT.
Procedure: VT ablation
Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT
Procedure: ICD Implantation
Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical
|
The main objective of this study is to compare the time from randomization to the first recurrence of any VT in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs) after an initial episode of stable VT and patients not undergoing ablation, with both groups under the protection of an ICD.
Prior to the ablation, the patients will undergo electrophysiologic study (EPS) with programmed ventricular stimulation, with the aim to reproduce the clinical VT. Most patients with coronary artery disease, systolic LV dysfunction, and one episode of clinical sustained VT have more than one inducible VT at electrophysiologic study. Since any inducible VT can become a potential clinical VT (24), an attempt will be made to ablate the clinical stable VT, as well as all inducible morphologies, stable or unstable.
One of the following 2 ablation strategies will be possible for each VT:
For each procedure the number of tachycardias , the type of each tachycardia (inducible or noninducible, stable or unstable), the ablation strategy for each tachycardia (it is possible that lesions deployed for one tachycardia will render another tachycardia noninducible as well) and the procedural outcome for each tachycardia will be documented.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |
| Institute for Clinical and Experimental Medicine | |
| Prague, Czech Republic, 140 21 | |
| Denmark | |
| University Hospital of Aarhus | |
| Aarhus, Denmark, 8200 | |
| Germany | |
| Universitäts Medizin Mannheim | |
| Mannheim, Baden-Württemberg, Germany, 68167 | |
| Herz- und Gefäßklinik Bad Neustadt | |
| Bad Neustadt, Bavaria, Germany, 97616 | |
| Klinikum Großhadern der Ludwig-Maximilians-Universität München | |
| München, Bavaria, Germany, 81377 | |
| Kerckhoff Klinik GmbH | |
| Bad Nauheim, Hesse, Germany, 61231 | |
| Klinikum der Johann Wolfgang Goethe-Universität Frankfurt | |
| Frankfurt, Hesse, Germany, 60596 | |
| Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität | |
| Bonn, Northrhine-Westphalia, Germany, 53127 | |
| Universitätsklinikum Münster | |
| Münster, Northrhine-Westphalia, Germany, 48149 | |
| Helios Klinikum Wuppertal Klinikum Barmen | |
| Wuppertal, Northrhine-Westphalia, Germany, 42283 | |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | |
| Ludwigshafen, Rhineland-Palatinate, Germany, 67063 | |
| Medizinische Fakultät der Universität Magdeburg | |
| Magdeburg, Saxony-Anhalt, Germany, 39120 | |
| Universitäres Herzzentrum Hamburg | |
| Hamburg, Germany, 20246 | |
| Asklepios Klinik St. Georg | |
| Hamburg, Germany, 20099 | |
| Klinikum der Ruprecht-Karls-Universität Heidelberg | |
| Heidelberg, Germany, 69120 | |
| Switzerland | |
| Universitätsspital Bern | |
| Berne, Switzerland, 3010 | |
| Principal Investigator: | Karl-Heinz Kuck, Prof. Dr. med. | Asklepios Klinik St. Georg, Hamburg, Germany |
More Information
| Responsible Party: | Frank Birkenhauer, St. Jude Medical GmbH |
| ClinicalTrials.gov Identifier: | NCT00919373 History of Changes |
| Other Study ID Numbers: | T46 |
| Study First Received: | June 10, 2009 |
| Last Updated: | June 11, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Catheter Ablation Defibrillators, Implantable |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Tachycardia Tachycardia, Ventricular Ventricular Dysfunction, Left Ventricular Dysfunction |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Arrhythmias, Cardiac Pathologic Processes |