Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy (VTACH)
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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 |
- recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- 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 . [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of adequate ICD interventions (shocks and overdrive episodes caused by recurrence of VT or VF and not supraventricular arrhythmias or mechanical lead problems). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| 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
|
|
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
|
Detailed Description:
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:
- Substrate modification in sinus rhythm in case of unstable induced monomorphic VT which does not allow mapping and ablation in tachycardia, or noninducible stable clinical VT.
- VT ablation in tachycardia in case of stable 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:
- Coronary artery disease 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 coronary artery, or 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, or history of successful thrombolysis, or a history of prior myocardial infarction (e.g.: documented by Q-wave, R-reduction, aneurysm)
- Left ventricular ejection fraction ≤ 50 % as estimated by echocardiography or contrast ventriculography within the previous 30 days and evidence for old myocardial infarction (ECG, echocardiographic or venticulographic).
- One episode of documented stable clinical VT without any reversible causes
- Written informed consent
Exclusion Criteria:
- Age < 18 years or > 80 year
- Protruding LV thrombus on pre-ablation echocardiogram
- Acute myocardial infarction within the preceding 1 months
- Class IV NYHA heart failure
- Valvular heart disease or mechanical heart valve precluding access to the left ventricle
- Unstable angina
- Cardiac surgery involving cardiotomy (not CABG) 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 in the study
- Participation in another investigational study
- Unwillingness to participate or lack of availability for follow-up
- Incessant VT or electrical storm
- Bundle branch reentry tachycardia as the presenting VT
- Preexisting ICD
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
No publications provided by St. Jude Medical
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by St. Jude Medical:
|
Catheter Ablation Defibrillators, Implantable |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 21, 2013