Safety and feasibility of IRE for PVI
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Acute efficacy: Acute pulmonary vein isolation with entrance and exit block
* Brain MRI: The occurrence of lesions on the DWI/FLAIR MRI will be scored as
yes/no and the number of lesions will be stored.
* Esophagoscopy: The occurrence of procedure related lesions, classified as: no
lesion, minimal lesion (small erythema/erosion with intact mucosa), severe
erythema/erosion and perforation
* Pulmonary vein diameter: The occurrence of pulmonary vein stenosis (> 50 %
reduction in diameter) as measured using the pre-CT-scan and post
contrast-enhanced MRI.
* Safety of investigational devices: Descriptive statistics will be used, for
example counts, means or medians. as appropriate.
Secondary outcome
* Procedure duration
* Fluoroscopy time
* Acute procedure related complications
* Feasibility and accuracy using MEIS during IRE ablation
* Cardiac enzymes levels related to IRE-ablation
* Cardiac function as determined using echocardiography
Background summary
Atrial fibrillation (AF), the most common cardiac arrhythmia. It is responsible
for significant morbidity and mortality in the general population mainly caused
by congestive heart failure and ischemic stroke. In case of symptomatic AF,
refractory or intolerant to antiarrhythmic medication, catheter ablation
treatment may be performed. In catheter ablation treatment, thermal lesions are
applied around the pulmonary vein ostia, thereby electrically isolating the PVs
from the left atrium. Catheter ablation can be performed using different
techniques. Most frequently, point-by-point ablations using radiofrequent (RF)
current are applied. Reasonable alternatives include circumferential RF,
cryoballoon and laserballoon ablations. Major disadvantages of current
therapies are risks of complications (PV stenosis, cerebral ischemia, phrenic
nerve palsy, esophageal or coronary damage) and the mediocre success rates,
especially after one procedure due to reconnection of the pulmonary veins (up
to 50%) and requering a second procedure. To overcome these disadvantages, our
research group investigated the potential of using a (low energy) direct
current (DC) circumferential ablation technique for cardiac ablation. With DC
the injury is not thermal mediated, but caused by a strong electrical field
that affects the lipid structure of the cell membrane leading to cell death.
This is called irreversible electroporation (IRE). Due to the non-thermal
nature of IRE ablation, it may be safer and more effective compared to current
techniques. In the pilot study 10/10 patients were treated succesfully and
without complications. The multi-electrode impedance system (MEIS) has been
developed to measure the level of contact between the catheteter and heart.
During this study MEIS will be used to perform measurements to assess the
feasibility of this system. The output of MEIS will not be used during the
procedure and thus will not influence the procedure.
Study objective
Safety and feasibility of IRE for PVI
Study design
Interventional
Intervention
Pulmonary vein antrum isolation with irreversible electroporation
Study burden and risks
The main difference with standard medical care is the use of the IRE circular
ablation catheter and application of IRE instead of RF energy. In addition to
standard care, an esophagoscopy and a cerebral and cardiac MRI will be
performed the day after the procedure, increasing the burden for participation
in comparison with standard care. The pilot study and previous animal studies
showed that the risks associated with IRE are low. A total of 10 patients were
treated successfully and without complications associated with the IRE
procedure during the pilot study. IRE might be more successful than RF
ablation. It also may avoid heat induced coagulum formation, cardiac
perforation due to tissue overheating, and heat induced PV stenosis.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
* Patients age is * 18 years and * 80 years
* Patients must provide written, informed consent
* Patients with paroxysmal or persistent atrial fibrillation. Persistent AF is defined as sustained episodes of atrial fibrillation lasting >7 days.
* Patients undergoing a first-time ablation procedure for atrial fibrillation
* All pulmonary vein diameters at computed tomography or magnetic resonance imaging *26 mm
* AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device
Exclusion criteria
* Not capable of giving informed consent
* Patients with longstanding persistent AF, defined as sustained episode lasting >1 year
* Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the LA (under conscious sedation), such as pregnancy or presence of a LA thrombus
* Patients that cannot undergo a contrast enhanced MRI-scan (e.g. implanted devices, renal function or anxiety)
* Patients that cannot undergo an esophagoscopy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69129.041.19 |