The objectives of this study are: 1) to assess the feasibility, accuracy and efficacy of simultaneous, conventional and micro-electrode mapping using the QDOT catheter to delineate and ablate the functional substrate of post-MI VT compared to…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mapping accuracy of the micro-electrodes of the QDOT catheter in re-
identifying evoked delayed potentials (EDP) detected by the Pentaray/Octrell
catheter and confirmation of EDP elimination.
Secondary outcome
- Mapping time using the QDOT catheter to delineate EDP compared to functional
substrate delineation with the Pentaray/Octrell catheter
- Wave-front and pacing-rate (coupling interval) dependency of QDOT micro/conv.
vs. Pentaray/Octrell for voltage mapping (=scar delineation) and functional
substrate mapping (=EDP identification)
- VT recurrence
- All course mortality
Background summary
A three-step approach is currently applied for functional substrate mapping and
ablation of ventricular tachycardia after myocardial infarction. First,
substrate mapping with a multipolar catheter with small and narrow-spaced
electrodes followed by ablation with a single-tip conventional catheter and
re-mapping with the multielectrode catheter. The QDOT ablation catheter
incorporates three microelectrodes in addition to the conventional bipolar
electrodes which may allow for identification of the functional substrate and
ablation with a single catheter.
Study objective
The objectives of this study are: 1) to assess the feasibility, accuracy and
efficacy of simultaneous, conventional and micro-electrode mapping using the
QDOT catheter to delineate and ablate the functional substrate of post-MI VT
compared to multielectrode mapping with the Pentaray/Octrell catheter for
different infarct subtypes (large transmural to subendocardial re-perfused MI),
2) to evaluate the potential benefit of combined mini - micro and conventional
electrode mapping for substrate delineation and ablation endpoint
determination, and 3) to establish a patient-tailored workflow for optimal
substrate mapping.
Study design
This will be a multi-center prospective observational study.
Study burden and risks
The burden associated with taking part in the study is a lengthened procedure
time (max. 20 minutes).
Patients in the evaluated group may benefit from participating in this study.
As with the QDOTcatheter operators may be able to re-confirm the functional VT
substrate before RF delivery at the exact same site, this may result in
improved substrate elimination and outcome. If the accuracy of the QDOT
catheter to detect evoked delayed potentials results to be similar than with
the Pentaray/Octrell catheter, and if with the QDOT catheter acute lesion
formation can be assessed, future patients might benefit from a shorter
procedure (no remapping required).
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Sustained within 6 months before enrolment.
- Accepted for catheter ablation of VT.
- Prior MI. The diagnosis of MI will be based on the presence of wall motion
abnormalities, non-reversible perfusion defects and/or subendocardial or
transmural late gadolinium enhancement areas in the perfusion territory of a
significant stenotic coronary artery (>75 %).
Exclusion criteria
- Age < 18 years
- Inadequate patient competence
- Pregnancy
- Presence of any of the following conditions:
o Non-ischemic left-dominant cardiomyopathy
o Right dominant cardiomyopathy
o Hypertrophic cardiomyopathy
o LV non-compaction cardiomyopathy
o Restrictive cardiomyopathy
o (Sub)acute myocarditis
o Cardiac sarcoidosis
o Chagas disease
o Tachycardia-induced cardiomyopathy
o Primary significant valve disease
o Congenital heart disease
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL74386.058.20 |