Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy

Not Applicable

Completed

• Conditions: Ventricular Tachycardia; Left Ventricular Dysfunction; Coronary Artery Disease
• Interventions: Procedure: Substrate modification; Procedure: VT ablation; Procedure: ICD Implantation

• Registration Number: NCT00919373
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICD + Ablation	ICD Implantation	Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation
ICD-Implantation	ICD Implantation	Implantation of an Implantable Cardioverter Defibrillator (ICD) alone.
ICD + Ablation	Substrate modification	Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation
ICD + Ablation	VT ablation	Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation

Primary Outcome Measures

Name	Time	Method
recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period	2 years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (16)

Medizinische Fakultät der Universität Magdeburg; 🇩🇪 Magdeburg, Saxony-Anhalt, Germany

Herz- und Gefäßklinik Bad Neustadt; 🇩🇪 Bad Neustadt, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt; 🇩🇪 Frankfurt, Hesse, Germany

Kerckhoff Klinik GmbH; 🇩🇪 Bad Nauheim, Hesse, Germany

University Hospital of Aarhus; 🇩🇰 Aarhus, Denmark

Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität; 🇩🇪 Bonn, Northrhine-Westphalia, Germany

Klinikum Großhadern der Ludwig-Maximilians-Universität München; 🇩🇪 München, Bavaria, Germany

Klinikum der Ruprecht-Karls-Universität Heidelberg; 🇩🇪 Heidelberg, Germany

Helios Klinikum Wuppertal Klinikum Barmen; 🇩🇪 Wuppertal, Northrhine-Westphalia, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; 🇩🇪 Ludwigshafen, Rhineland-Palatinate, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Czechia

Universitäts Medizin Mannheim; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Northrhine-Westphalia, Germany

Universitätsspital Bern; 🇨🇭 Berne, Switzerland