The primary objective is to evaluate the antral lesion size using ultrahighdensity (UHDx) mapping pre- and post-cryoablation with the 31 mm balloon size CB. Secondary objectives are the proportion of pulmonary veins (PVs) where a 31 mm CB could be…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the extent of the antral lesion size.
Secondary outcome
Secondary endpoints are the proportion of PVs with grade 4 occlusion with the
31 mm balloon size CB, the single shot success rate of the 31 mm balloon size
CB, difference in rate of achieving grade 4 occlusion in comparison to the
standard (28 mm) size.
Background summary
The next generation POLARx cryoablation balloon (CB) catheter will have the
option of to deliver cryotherapy with the current balloon size of 28 mm or a
new, larger 31 mm size by changing the inner balloon pressure (POLARx FIT,
Boston Scientific). Currently, there is no data on the extension of left atrial
(LA) lesion formation with the 31 mm balloon size of the POLARx FIT
cryoablation balloon catheter. The hypothesis is that a larger CB size results
in a wide antral circumferential lesion.
Study objective
The primary objective is to evaluate the antral lesion size using
ultrahighdensity (UHDx) mapping pre- and post-cryoablation with the 31 mm
balloon size CB. Secondary objectives are the proportion of pulmonary veins
(PVs) where a 31 mm CB could be positioned to achieve a grade 4 occlusion and
the single shot success rate with the 31 mm balloon size CB.
Study design
Single-center, single-arm, prospective study with pre- and post-PVI UHDx
mapping. Patients will undergo pre- and post-ablation UHDx mapping (Orion
catheter and Rhythmia 3D-mapping system, Boston Scientific) during the index
procedure.
Study burden and risks
A UHDx mapping will be acquired before and after complete PVI. The procedures
will be performed under deep sedation, which is standard practice for CB
procedures in our institution. The risk of additional mapping is limited. LA
mapping is a standard diagnostic method for patients undergoing PVI with
radiofrequency (*standard-of-care*). In the current study, UHDx mapping will
now be used in patients undergoing PVI with CB. The most important complication
of additional intracardiac mapping is cardiac tamponade, but this risk is low
(<0.5%).
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. History of symptomatic paroxysmal AF
2. Subjects who are indicated for a PVI according to the 2020 ESC guidelines
for the diagnosis and management of AF
3. Subjects who are willing and capable of providing informed consent
4. Subjects who are willing and capable of participating in all testing
associated with this clinical investigation
5. Subjects whose age is 18 years or above
Exclusion criteria
1. Any known contraindication to an AF ablation or anticoagulation
2. History of previous left atrial ablation or surgical treatment of AF, atrial
flutter, or atrial tachycardia
3. AF secondary to electrolyte imbalance, thyroid disease, or any other
reversible or noncardiac cause
4. Significant structural heart disease
5. History of blood clotting or bleeding disease
6. Stroke or transient ischemic attack <3 months prior to enrollment
7. Active systemic infection
8. Common ostium PV >24 mm defined by CT-scan
9. Pregnant, lactating, or women of childbearing potential who are, or plan to
become, pregnant during the time of the study
10. Subjects who are currently enrolled in another investigational study or
registry that would directly interfere with the current study
Design
Recruitment
Medical products/devices used
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 | NCT05881733 |
| CCMO | NL84423.078.23 |