We hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
ID
Bron
Verkorte titel
Aandoening
scar related ventricular tachycardia
dutch: ventrikel tachycardie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on ICD interrogation - between the two ablation groups
Achtergrond van het onderzoek
The objective of this study is to show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.
Study design: Multicenter prospective open randomized controlled trial.
Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.
Doel van het onderzoek
We hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
Onderzoeksopzet
2 years follow-up
Onderzoeksproduct en/of interventie
One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.
Algemeen / deelnemers
Astrid Hendriks
‘s Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31-10-7033318
a.a.hendriks@erasmusms.nl
Wetenschappers
Astrid Hendriks
‘s Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31-10-7033318
a.a.hendriks@erasmusms.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
2. history of ischemic heart disease
3. ICD carrier or ICD implantation planned after the ablation
4. informed written consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. current unstable angina as defined by current european guidelines
2. AMI < 30 days or in case of incessant VT < 14 days
3. absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
4. significant coronary stenosis approachable and clinically relevant for intervention
5. presence of a mobile left ventricle thrombus seen on (contrast) echocardiograpy or MRI
6. previous pericarditis
7. presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions
8. previous thoracic radiation therapy
9. contra-indication for general anaesthesia
10. age below 18 years
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4989 |
| NTR-old | NTR5136 |
| Ander register | MEC : 2014-248 |