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

Coronary Artery Disease Clinical Trial

— VTACH  

Official title:

Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919373
• Other study ID #: T46
• Status: Completed
• Phase: N/A
• Start date: July 2002
• Est. completion date: January 2006

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Left Ventricular Dysfunction
• Myocardial Ischemia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Dysfunction
• Ventricular Dysfunction, Left
• Ventricular Tachycardia

Intervention

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.
• VT ablation
Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT
• ICD Implantation
Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague
Denmark	University Hospital of Aarhus	Aarhus
Germany	Kerckhoff Klinik GmbH	Bad Nauheim	Hesse
Germany	Herz- und Gefäßklinik Bad Neustadt	Bad Neustadt	Bavaria
Germany	Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität	Bonn	Northrhine-Westphalia
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt	Hesse
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Klinikum der Ruprecht-Karls-Universität Heidelberg	Heidelberg
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen	Rhineland-Palatinate
Germany	Medizinische Fakultät der Universität Magdeburg	Magdeburg	Saxony-Anhalt
Germany	Universitäts Medizin Mannheim	Mannheim	Baden-Württemberg
Germany	Klinikum Großhadern der Ludwig-Maximilians-Universität München	München	Bavaria
Germany	Universitätsklinikum Münster	Münster	Northrhine-Westphalia
Germany	Helios Klinikum Wuppertal Klinikum Barmen	Wuppertal	Northrhine-Westphalia
Switzerland	Universitätsspital Bern	Berne

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Czechia,  Denmark,  Germany,  Switzerland, 

References & Publications (1)

Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz 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 hear — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period		2 years
Secondary	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
Secondary	Quality of life		2 years
Secondary	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