This study is designed to investigate successful left common PV antrum isolation and to determine lesion characteristics after PFA in patients with AF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful LCO isolation after PFA in patients with AF*
*LCO is successful if the scar location is within +/- 10mm of the average of
the line drawn by the operator at each measurement point
Secondary outcome
- successful isolation at each measuring point (superior, mid-posterior and
inferior, as shown in Figure 3)
- distance between the left and right lesion (measured superior, mid posterior
and inferior)
- correlation between posterior wall conduction speed and the left and right
lesion distance
- safety outcomes within the hospital stay
- Vascular complication (defined as a major or minor vascular complication from
the Valve Academic Research Consortium-2)
- Bleeding complication (defined as Bleeding Academic Research Consortium type
2 or higher)
- Tamponade, for which an intervention is required
- Transient phrenic nerve palsy (lasting < 24 hours)
- Persistent phrenic nerve palsy (lasting >= 24 hours)
- Thromboembolic event
- Admission for more than 24 hours post procedure and the reason for prolonged
admission.
- number of patients with successful same day discharge
- interoperator variability of the line drawn in the anatomical map
- pulmonary vein isolation demonstrated with the ablation catheter and a
mapping system
Background summary
Pulmonary vein isolation is the cornerstone in the invasive treatment of atrial
fibrillation. Ectopic beats originating from the pulmonary veins have been
identified as trigger for atrial fibrillation. During pulmonary vein isolation,
a lesion is formed around the pulmonary veins that electrically dissociates the
pulmonary veins from the atrium.
Pulsed field ablation has recently been introduced as new ablation modality.
Pulsed field ablation uses short coupled high voltage trains to damage the cell
mebrane to create a lesion. Ideally, the location of the lesion is located at
the atrium of the pulmonary veins. However, in anatomical variations, such as
the presence of a left common ostium, creating an antral lesion can potentially
be challenging. We know from previous studies that patients who were treated
with cryoballoon ablation had worse outcomes compared to patients who were
treated with conventional radiofrequency ablation. A possible given explanation
is the location of the ablation lesion. During pulsed-field ablation, tissue
contact is less critical and we assume that this ablation therapy also result
in good antral isolation in patients with a left common ostium. However, the
main focus of re-map studies was on patients with four saperated pulmonary
veins.
In this study we will investigate the lesioncharacteristics after pulsed field
ablation in patients with atrial fibrillation and a left common ostium.
Study objective
This study is designed to investigate successful left common PV antrum
isolation and to determine lesion characteristics after PFA in patients with
AF.
Study design
Nineteen patients will be prospetively included in OLVG. All patients will be
treated with pulsed field ablation (routine care). After the ablation
procedure, an electro-anatomical map will be created using the ablationcatheter
and a mapping system. This map will display the left atrium and the lesion in
detail.
After the pocedure, three experienced operators are asked to draw a line around
the LCO in the anatomical map where they would have ablated if conventional
radiofrequency ablation was used. Only the anatomy of the left atrium will be
visible, and the operators are thus blinded for voltage. The distance between
the drawn line and the ablation lesion will be measured at three predefined
points. The lesion is considered successful if the mean distance is within
±10mm at all measurement points.
Study burden and risks
The complexity of this study protocol is low. In addition to the pulsed field
ablation we will create an electro-anatomical map concomitantly with the
confirmation round. To obtain clean intracardial signals, the ablation catheter
has to be moved more slowly and more frequently. This will increase the left
atrial dwelling time by approximately 5 - 10 minutes. As the electro-anatomical
map is created during the last confirmation round, we believe that the risks of
extra dwelling time are low. However, the adverse events can be moderate.
During pulsed field ablation, pericardial effusion and tromboemobolic
complications occur in 1% and 0.4% respectively. From the literature it is
unclear to what extent an electro-anatomical map increases this risks. An
electro-anatomical is created in many ablation procedures. We believe, based on
our experience, that the additional risk is very limited. The benefit of the
electro-anatomical map includes an extra confirmation of durable pulmonary vein
isolation using a mapping system. Whereas, it has shown that high-density
mapping revealed pulmonary vein reconnection after pulsed field ablation in 6%
of the patients. Additional ablation applications will be delivered if there is
any sign of pulmonary vein reconnection on the electro-anatomical map.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years of age on the day of enrolment of either sex
- Willing to sign informed consent
- Left atrial volume index measured < 60 ml/m2 within last 12 months
- Documented atrial fibrillation
- Admitted and accepted for PVI
- A left common ostium of the pulmonary veins identified by CT or MRI
- Accepted to receive general anaesthesia
Exclusion criteria
- Patients age < 18
- Body mass index > 35kg/m2
- Left atrial volume index >= 60 ml/m2 within 12 months on MRI or cardiac echo
- New York Heart Association heart failure class III or IV
- Myocardial infarction within three months before the procedure
- Unstable angina pectoris
- Percutaneous coronary interventions within three months before the procedure
- Sudden cardiac death event within three months before the procedure
- Life expectancy of less than one year
- Presence of an atrial tachycardia other than cavotricuspid isthmus dependent
atrial flutter
- History of blood clotting or bleeding abnormalities
- History of a thromboembolic event within six months before the procedure
- A contraindication to anticoagulant
- Clinical significant infection
- Unstable clinical significant medical condition
- Previous left atrium ablation, except successful accessory pathway ablation
- Presence of a left appendage closure device
- Presence of an atrial septum occluder
- Presence of a prosthetic heart valve
- Occlusion of the inferior venous tract
- Enrolment in another study that would interfere with this study
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 |
|---|---|
| ClinicalTrials.gov | NCT05812261 |
| CCMO | NL84128.100.23 |