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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD-Implantation | Active Comparator | Implantation of an Implantable Cardioverter Defibrillator (ICD) alone. |
|
| ICD + Ablation | Active Comparator | Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Substrate modification | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Severe clinical events (death, number of syncopes, number of hospital admissions for a cardiac indication, number of episodes of electrical storm (more than 3 VT episodes in 24 hours)) during the follow-up period . | 2 years | |
| Quality of life | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Heinz Kuck, Prof. Dr. | Asklepios Klinik St. Georg, Hamburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine | Prague | 140 21 | Czechia | |||
| University Hospital of Aarhus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20109864 | Result | Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacretaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4. |
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| VT ablation | Procedure | Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT |
|
| ICD Implantation | Procedure | Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical |
|
| Number of adequate ICD interventions (shocks and overdrive episodes caused by recurrence of VT or VF and not supraventricular arrhythmias or mechanical lead problems). | 2 years |
| Aarhus |
| 8200 |
| Denmark |
| Universitäts Medizin Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Herz- und Gefäßklinik Bad Neustadt | Bad Neustadt an der Saale | Bavaria | 97616 | Germany |
| Klinikum Großhadern der Ludwig-Maximilians-Universität München | München | Bavaria | 81377 | Germany |
| Kerckhoff Klinik GmbH | Bad Nauheim | Hesse | 61231 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universität Frankfurt | Frankfurt am Main | Hesse | 60596 | Germany |
| Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Helios Klinikum Wuppertal Klinikum Barmen | Wuppertal | North Rhine-Westphalia | 42283 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| Medizinische Fakultät der Universität Magdeburg | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| Klinikum der Ruprecht-Karls-Universität Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsspital Bern | Bern | 3010 | Switzerland |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D003324 | Coronary Artery Disease |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |
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