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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00919373
First received: June 10, 2009
Last updated: July 26, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919373

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
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Karl-Heinz Kuck, Prof. Dr. Asklepios Klinik St. Georg, Hamburg, Germany
  More Information

Publications:
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00919373     History of Changes
Other Study ID Numbers: T46
Study First Received: June 10, 2009
Last Updated: July 26, 2013
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 July 26, 2014