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

Primary Purpose

Ventricular Tachycardia, Coronary Artery Disease, Left Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Substrate modification
VT ablation
ICD Implantation
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Catheter Ablation, Defibrillators, Implantable

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Clinical and Experimental Medicine
  • University Hospital of Aarhus
  • Universitäts Medizin Mannheim
  • Herz- und Gefäßklinik Bad Neustadt
  • Klinikum Großhadern der Ludwig-Maximilians-Universität München
  • Kerckhoff Klinik GmbH
  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
  • Universitätsklinikum Münster
  • Helios Klinikum Wuppertal Klinikum Barmen
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Medizinische Fakultät der Universität Magdeburg
  • Asklepios Klinik St. Georg
  • Universitäres Herzzentrum Hamburg
  • Klinikum der Ruprecht-Karls-Universität Heidelberg
  • Universitätsspital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ICD-Implantation

ICD + Ablation

Arm Description

Implantation of an Implantable Cardioverter Defibrillator (ICD) alone.

Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation

Outcomes

Primary Outcome Measures

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

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 .
Quality of life
Number of adequate ICD interventions (shocks and overdrive episodes caused by recurrence of VT or VF and not supraventricular arrhythmias or mechanical lead problems).

Full Information

First Posted
June 10, 2009
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00919373
Brief Title
Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy
Acronym
VTACH
Official Title
Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Coronary Artery Disease, Left Ventricular Dysfunction
Keywords
Catheter Ablation, Defibrillators, Implantable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICD-Implantation
Arm Type
Active Comparator
Arm Description
Implantation of an Implantable Cardioverter Defibrillator (ICD) alone.
Arm Title
ICD + Ablation
Arm Type
Active Comparator
Arm Description
Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation
Intervention Type
Procedure
Intervention Name(s)
Substrate modification
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
VT ablation
Intervention Description
Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT
Intervention Type
Procedure
Intervention Name(s)
ICD Implantation
Intervention Description
Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical
Primary Outcome Measure Information:
Title
recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Title
Quality of life
Time Frame
2 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, Prof. Dr.
Organizational Affiliation
Asklepios Klinik St. Georg, Hamburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
University Hospital of Aarhus
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Universitäts Medizin Mannheim
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Herz- und Gefäßklinik Bad Neustadt
City
Bad Neustadt
State/Province
Bavaria
ZIP/Postal Code
97616
Country
Germany
Facility Name
Klinikum Großhadern der Ludwig-Maximilians-Universität München
City
München
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Facility Name
Kerckhoff Klinik GmbH
City
Bad Nauheim
State/Province
Hesse
ZIP/Postal Code
61231
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60596
Country
Germany
Facility Name
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
City
Bonn
State/Province
Northrhine-Westphalia
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Northrhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
Helios Klinikum Wuppertal Klinikum Barmen
City
Wuppertal
State/Province
Northrhine-Westphalia
ZIP/Postal Code
42283
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
State/Province
Rhineland-Palatinate
ZIP/Postal Code
67063
Country
Germany
Facility Name
Medizinische Fakultät der Universität Magdeburg
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
39120
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Klinikum der Ruprecht-Karls-Universität Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsspital Bern
City
Berne
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20109864
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.
Results Reference
result

Learn more about this trial

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

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