Clinical trial NCT00919373: Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy
Official title: Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Coronary Artery Disease
Left Ventricular Dysfunction
Keywords: Catheter Ablation
Defibrillators, Implantable
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period
timeFrame: 2 years
Secondary outcomes:
measure: 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 .
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: Number of adequate ICD interventions (shocks and overdrive episodes caused by recurrence of VT or VF and not supraventricular arrhythmias or mechanical lead problems).
timeFrame: 2 years
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Aarhus
country: Denmark
facility: University Hospital of Aarhus
city: Mannheim
country: Germany
facility: Universitäts Medizin Mannheim
state: Baden-Württemberg
city: Bad Neustadt
country: Germany
facility: Herz- und Gefäßklinik Bad Neustadt
state: Bavaria
city: München
country: Germany
facility: Klinikum Großhadern der Ludwig-Maximilians-Universität München
state: Bavaria
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik GmbH
state: Hesse
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hesse
city: Bonn
country: Germany
facility: Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
state: Northrhine-Westphalia
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Northrhine-Westphalia
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal Klinikum Barmen
state: Northrhine-Westphalia
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
state: Rhineland-Palatinate
city: Magdeburg
country: Germany
facility: Medizinische Fakultät der Universität Magdeburg
state: Saxony-Anhalt
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Heidelberg
country: Germany
facility: Klinikum der Ruprecht-Karls-Universität Heidelberg
city: Berne
country: Switzerland
facility: Universitätsspital Bern
Study officials:
affiliation: Asklepios Klinik St. Georg, Hamburg, Germany
name: Karl-Heinz Kuck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.