NCT00919373

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
4 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

3.5 years

First QC Date

June 10, 2009

Last Update Submit

February 1, 2019

Conditions

Ventricular TachycardiaCoronary Artery DiseaseLeft Ventricular Dysfunction

Keywords

Catheter AblationDefibrillators, Implantable

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (3)

  • 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

  • Quality of life

    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

Study Arms (2)

ICD-Implantation

ACTIVE COMPARATOR

Implantation of an Implantable Cardioverter Defibrillator (ICD) alone.

Procedure: ICD Implantation

ICD + Ablation

ACTIVE COMPARATOR

Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation

Procedure: Substrate modificationProcedure: VT ablationProcedure: ICD Implantation

Interventions

Substrate modificationPROCEDURE

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.

ICD + Ablation
VT ablationPROCEDURE

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

ICD + Ablation
ICD ImplantationPROCEDURE

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

ICD + AblationICD-Implantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Institute for Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

University Hospital of Aarhus

Aarhus, 8200, Denmark

Location

Universitäts Medizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Herz- und Gefäßklinik Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Klinikum Großhadern der Ludwig-Maximilians-Universität München

München, Bavaria, 81377, Germany

Location

Kerckhoff Klinik GmbH

Bad Nauheim, Hesse, 61231, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, 60596, Germany

Location

Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Helios Klinikum Wuppertal Klinikum Barmen

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

Medizinische Fakultät der Universität Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Klinikum der Ruprecht-Karls-Universität Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsspital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 20109864RESULT

MeSH Terms

Conditions

Tachycardia, VentricularCoronary Artery DiseaseVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesVentricular Dysfunction

Study Officials

  • Karl-Heinz Kuck, Prof. Dr.

    Asklepios Klinik St. Georg, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

July 1, 2002

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

CZ(1)DK(1)DE(13)CH(1)