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

Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ventricular Tachycardia; Left Ventricular Dysfunction
• Intervention / Treatment: Procedure: ICD Implantation; Procedure: Substrate modification; Procedure: VT ablation

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 140 21
    • Institute for Clinical and Experimental Medicine
• Denmark
  • Aarhus, Denmark, 8200
    • University Hospital of Aarhus
• Germany
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 20246
    • Universitares Herzzentrum Hamburg
  • Heidelberg, Germany, 69120
    • Klinikum der Ruprecht-Karls-Universität Heidelberg
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Universitäts Medizin Mannheim
  • Bavaria
    • Bad Neustadt, Bavaria, Germany, 97616
      • Herz- und Gefäßklinik Bad Neustadt
    • München, Bavaria, Germany, 81377
      • Klinikum Großhadern der Ludwig-Maximilians-Universität München
  • Hesse
    • Bad Nauheim, Hesse, Germany, 61231
      • Kerckhoff Klinik GmbH
    • Frankfurt, Hesse, Germany, 60596
      • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Northrhine-Westphalia
    • Bonn, Northrhine-Westphalia, Germany, 53127
      • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
    • Münster, Northrhine-Westphalia, Germany, 48149
      • Universitatsklinikum Munster
    • Wuppertal, Northrhine-Westphalia, Germany, 42283
      • Helios Klinikum Wuppertal Klinikum Barmen
  • Rhineland-Palatinate
    • Ludwigshafen, Rhineland-Palatinate, Germany, 67063
      • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Medizinische Fakultät der Universität Magdeburg
• Switzerland
  • Berne, Switzerland, 3010
    • Universitätsspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: ICD Implantation; Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	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
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Karl-Heinz Kuck, Prof. Dr., Asklepios Klinik St. Georg, Hamburg, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 11, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Catheter Ablation; Defibrillators, Implantable
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Cardiac Conduction System Disease; Coronary Artery Disease; Tachycardia; Tachycardia, Ventricular; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: T46