Ventricular TachycardiaVTACHNCT00919373
Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy
A study testing Substrate modification, VT ablation and ICD Implantation in people with Ventricular Tachycardia and Coronary Artery Disease, run by Abbott Medical Devices at 16 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia, Coronary Artery Disease, Left Ventricular Dysfunction
- What is being tested?
- Substrate modification, VT ablation and ICD Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Jul 2002to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Germany13 sites
Kerckhoff Klinik GmbH
Bad Nauheim, Hesse, 61231
Herz- und Gefäßklinik Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
Bonn, North Rhine-Westphalia, 53127
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60596
Asklepios Klinik St. Georg
Hamburg, 20099
Universitäres Herzzentrum Hamburg
Hamburg, 20246
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg, 69120
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
Medizinische Fakultät der Universität Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Universitäts Medizin Mannheim
Mannheim, Baden-Wurttemberg, 68167
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, Bavaria, 81377
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Helios Klinikum Wuppertal Klinikum Barmen
Wuppertal, North Rhine-Westphalia, 42283
About this study
Official title: Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy
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.
Read the 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.
- Being tested
- Substrate modification, VT ablation, ICD Implantation
- Keywords
- Catheter Ablation, Defibrillators, Implantable
- Medical subject headings
- Tachycardia, Ventricular, Coronary Artery Disease, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substrate modificationProcedure or surgery
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 ablationProcedure or surgery
Catheter Ablation of Ventricular Tachycardia (VT) in case of stable VT
ICD ImplantationProcedure or surgery
Implantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical
| Study group | Role | What they receive |
|---|---|---|
| ICD-Implantation | Active comparator | Implantation of an Implantable Cardioverter Defibrillator (ICD) alone. Receives: Procedure: ICD Implantation |
| ICD + Ablation | Active comparator | Stratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation Receives: Procedure: Substrate modification; Procedure: VT ablation; Procedure: ICD Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period
Measured: 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 .
Measured: 2 years
Quality of life
Measured: 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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJul 2002
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, Prof. Dr., Principal investigator, Asklepios Klinik St. Georg, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919373
- Sponsor's protocol ID
- T46
- Acronym
- VTACH
- Status last verified
- Feb 2019
- First submitted
- 10 Jun 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20109864
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Modification in Stable Ventricular Tachycardia in Addition to ICD Therapy
- ClinicalTrials.gov ID
- NCT00919373
- Acronym / sponsor ID
- VTACH / T46
- Keywords
- Catheter Ablation, Defibrillators, Implantable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD-Implantation | Active comparator | Procedure: ICD ImplantationImplantation of an Implantable Cardioverter Defibrillator (ICD) alone. |
| ICD + Ablation | Active comparator | Procedure: Substrate modification, Procedure: VT ablation, Procedure: ICD ImplantationStratified Catheter Ablation of Ventricular Tachycardia and ICD Implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substrate modificationCatheter 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 or surgery | ICD + Ablation |
| VT ablationCatheter Ablation of Ventricular Tachycardia (VT) in case of stable VT | Procedure or surgery | ICD + Ablation |
| ICD ImplantationImplantation of a marked released Implantable Cardioverter Defibrillator manufactured by St. Jude Medical | Procedure or surgery | ICD + Ablation, ICD-Implantation |
Primary outcome
recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period
Time frame: 2 years
3 secondary outcomes
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
Quality of life
Time frame: 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).
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Results publication: PubMed 20109864Kuck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Heinz Kuck, Prof. Dr. principal investigator
Asklepios Klinik St. Georg, Hamburg, Germany
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Substrate modification, VT ablation and ICD Implantation in people with Ventricular Tachycardia and Coronary Artery Disease, run by Abbott Medical Devices at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Czechia, Denmark, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of any sustained clinical VT, stable or unstable, monomorphic or polymorphic, including VF, during the follow-up period (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.