The main objectives of this study are (1) to evaluate the acute electrophysiological effect of endocardial versus combined endo/epicardial encircling cryoablation, (2) to determine if substrate isolation can be achieved by endocardial or combined…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study will test the hypothesis that the combined endo- and epicardial
ablation therapy but not the endocardial ablation will result in isolation of
the VA substrate and that the combined approach will be more effective in
preventing reinducibility and spontaneous occurrence of VA. The main study
parameters are acute conduction properties across the ablation line
intraoperatively. inducibility of VTs before and after surgery and spontaneous
VA as registered by the internal cardiac defibrillator.
Secondary outcome
Secundary study parameters include inducibility of VTs before and after surgery
and spontaneous VA as registered by the internal cardiac defibrillator.
Background summary
Encircling endocardial cryoablation of postinfarction left ventricular (LV)
aneurysm without mapping, concomitant with LV reconstruction by endoventricular
circular patch plasty can be effective to treat sustained ventricular
tachycardia (VT). However, insights into the underlying mechanism of the
procedure (endocardial substrate modification or substrate isolation) are
lacking and a significant number of patients remain inducible after surgery.
Procedural failure becomes important, if the VT origin is excluded from the
endocardium by patch material, preventing catheter ablation
Study objective
The main objectives of this study are (1) to evaluate the acute
electrophysiological effect of endocardial versus combined endo/epicardial
encircling cryoablation, (2) to determine if substrate isolation can be
achieved by endocardial or combined endo/epicardial ablations and (3) to assess
whether the combined endo- and epicardial approach is more effective than the
endocardial approach alone in preventing inducibility of ventricular
arrhythmia.
Study design
A monocenter prospective randomized open-label trail.
Intervention
40 patients are randomized to either both endocardial and epicardial
cryoablation of borderzone of myocardial scar or endocardial cryoablation
alone.
Study burden and risks
Both surgical endocardial and epicardial cryoablation of borderzone of
ventricular myocardial scar are feasible and clinically used treatment
modalities. The combined approach of endo and epicardial encircling
cryoablation is not expected to carry more risk than the endocardial
cryoablation alone. Conduction time measurements done during the surgical
procedure to establish the effect of cryoablation take limited time and are not
expected to negatively influence the result of surgery.
Furthermore study patients will be treated according to the currently valid
treatment protocol.
Albinusdreef 2
2333 ZA, Leiden
NL
Albinusdreef 2
2333 ZA, Leiden
NL
Listed location countries
Age
Inclusion criteria
Acceptation for surgical left ventricular reconstruction according to Dor
Spontaneous or inducible ventricular arrhythmia
Exclusion criteria
Age<18 year
Unability to comply with the protocol
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 | NL20420.058.07 |