See also:
All patients with implantable cardioverter defibrillators clinical trials
All ventricular tachycardia in patients with structural heart disease clinical trials
All clinical trials of catheter ablation of ventricular tachycardia
All clinical trials of catheter ablation before ICD
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VTACH study, 2009
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[NCT00919373]
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Treatments
| Studied treatment |
catheter ablation for ventricular tachycardia (VT) plus implantable cardioverter defibrillator
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| Control treatment |
implantable cardioverter defibrillator alone
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Patients
| Patients |
Patients undergoing implantation of an ICD Patients undergoing implantation of an ICD |
| Inclusion criteria |
patients aged 18¡ª80 years with stable VT, previous myocardial infarction, and reduced left-ventricular ejection fraction (LVEF; ¡Ü50%). |
| Exclusion criteria |
myocardial infarction within the last month; cardiac surgery within the last 2 months; LV thrombus; valvular heart disease or mechanical heart valve; unstable angina; incessant VT; bundle branch re-entry tachycardia; contraindication to heparin;renal insufficiency;rdvanced heart failure; expected survival <12 months |
| Baseline characteristics |
| Age (mean), years |
66y |
| Men (%) |
93% |
| LVEF (mean), % |
66% |
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Method and design
| Randomized effectives |
54 / 56 (studied vs. control) |
| Design |
Parallel groups |
| Blinding |
open |
| Follow-up duration |
27 mo |
| Lost to follow-up |
2.7% (3) |
| Number of centre |
16 |
| Geographic area |
Europe |
| Primary endpoint |
first VT or ventricular fibrillation |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
VT or VF
NA / 54
NA / 56
0,61 [0,37;1,00]
Syncope
NA / 54
NA / 56
0,36 [0,07;1,83]
all ICD shock (appropriate and inappropriate)
17 / 54
29 / 56
0,61 [0,38;0,97]
Appropriate ICD shock
26 / 54
38 / 56
0,71 [0,51;0,99]
hospitalisation for cardiovascular causes
NA / 54
NA / 56
0,55 [0,30;1,00]
All cause death
NA / 54
NA / 56
classic
1,32 [0,35;4,96]
Inappropriate ICD shock
4 / 54
6 / 56
classic
0,69 [0,21;2,32]
0
2
1.0
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Relative risks
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| Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
| Studied treat. |
Control treat. |
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all ICD shock (appropriate and inappropriate)
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17 / 54 (31,5%) |
29 / 56 (51,8%) |
0,61 |
[0,38;0,97] |
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12008 |
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Appropriate ICD shock
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26 / 54 (48,1%) |
38 / 56 (67,9%) |
0,71 |
[0,51;0,99] |
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12008 |
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Inappropriate ICD shock
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4 / 54 (7,4%) |
6 / 56 (10,7%) |
0,69 |
[0,21;2,32] |
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12008 |
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The primary endpoint (if exists) appears in blod characters
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Reference(s) used for data extraction:
12008: Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PSCatheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial.Lancet 2010 Jan 2;375:31-40
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| Endpoint |
studied treat. |
control treat. |
mean diff |
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Absolute risk reduction
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| Endpoint |
Events rate |
Absolute risk reduction (ARR) |
| Studied treat. |
Control treat. |
| all ICD shock (appropriate and inappropriate) |
31,48% |
51,79% |
-203,0‰
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| Appropriate ICD shock |
48,15% |
67,86% |
-197,1‰
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| Inappropriate ICD shock |
7,41% |
10,71% |
-33,1‰
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Reference(s)
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Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS.
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;375:31-40
Pubmed
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Hubmed
| Fulltext
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