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.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
Procedure success and safety.
Background summary
Nowadays VT ablation in structural heart disease is performed primarily by
early referral; while at the same time we still struggle with the limited
longterm ablation success of endocardial VT ablation. An underestimated number
of VTs from ischemic substrate have an epicardial exit. However, one cannot
accurately predict who is in need of epicardial ablation. 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.
Study objective
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.
Intervention
Combined endo/epicardial substrate homogenization in a first approach
Study burden and risks
There will be few additional discomforts related to the study for patients
participating in this study. All treatment arms are part of current treatment
practice. Risk associated with epicardial VT ablation is acceptably low and
physical discomfort associated with pericardial access is generally mild and
self-limiting. There is a low risk of tamponade and perforation of surrounding
tissue. Subjects participating in the study will possibly have less recurrence
of VT and subsequently a lower incidence of ICD therapy. There will be no
additional burden on follow-up, where the frequency of ICD interrogation in
this population is as clinically indicated.
Molewaterplein 40
Rotterdam 3015 GD
NL
Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
1. current unstable angina
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 for intervention
5. presence of a mobile left ventricle thrombus
5. previous pericarditis
6. presence of mitral/aortic mechanical valves prosthesis; previous coronary
artery bypass graft; any other thoracic surgery that could cause pericardial
adhesions
7. contra-indication for general anaesthesia
8. age below 18 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL48168.078.14 |