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

NCT ID: NCT00919373

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2006-01-31

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.

Conditions

Ventricular Tachycardia; Coronary Artery Disease; Left Ventricular Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICD-Implantation

Implantation of an Implantable Cardioverter Defibrillator (ICD) alone.

Group Type: ACTIVE_COMPARATOR

ICD Implantation

Intervention Type: PROCEDURE

Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical

ICD + Ablation

Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation

Group Type: ACTIVE_COMPARATOR

Substrate modification

Intervention Type: PROCEDURE

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.

VT ablation

Intervention Type: PROCEDURE

Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT

ICD Implantation

Intervention Type: PROCEDURE

Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical

Interventions

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.

Intervention Type: PROCEDURE

VT ablation

Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT

Intervention Type: PROCEDURE

ICD Implantation

Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl-Heinz Kuck, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik St. Georg, Hamburg, Germany

Locations

Institute for Clinical and Experimental Medicine

Prague, , Czechia

University Hospital of Aarhus

Aarhus, , Denmark

Universitäts Medizin Mannheim

Mannheim, Baden-Wurttemberg, Germany

Herz- und Gefäßklinik Bad Neustadt

Bad Neustadt an der Saale, Bavaria, Germany

Klinikum Großhadern der Ludwig-Maximilians-Universität München

München, Bavaria, Germany

Kerckhoff Klinik GmbH

Bad Nauheim, Hesse, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, Germany

Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Helios Klinikum Wuppertal Klinikum Barmen

Wuppertal, North Rhine-Westphalia, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Medizinische Fakultät der Universität Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Klinikum der Ruprecht-Karls-Universität Heidelberg

Heidelberg, , Germany

Universitätsspital Bern

Bern, , Switzerland

Countries

Czechia; Denmark; Germany; Switzerland

References

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.

Reference Type: RESULT

PMID: 20109864 (View on PubMed)

Other Identifiers

T46

Identifier Type: -

Identifier Source: org_study_id