To study the effect of grid visualization during PVI on procedure times, to study the effect of grid visualization on acquiring direct isolation after encircling the pulmonary veins (*single round* ), to study the effect of grid visualization on the…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
procedure time, defined as time from first RF lesion to last RF lesion. Last RF
lesion may be last RF of completion of pulmonary vein encircling combined with
direct isolation (single round isolation), last RF for isolation if additional
touch-up lesions are necessary or last RF to achieve re-isolation in case of
reconnection during the procedure
Secondary outcome
percentage single round isolation for each PV pair, defined as complete
isolation occurring without the need of additional *touch ups*
freedom from atrial arrhythmia at follow-up, defined as atrial fibrillation,
atrial flutter or atrial tachycardia demonstrated by a valid ECG tracing
obtained after the 90-day post-ablation blanking period
Background summary
Freedom of atrial fibrillation (AF) after pulmonary vein isolation (PVI) is
limited to 50-80% of patients, dependent on patient characteristics. This is
typically due to electrical reconnection between the pulmonary veins and the
left atrium at follow-up. Efforts to optimize outcome of catheter ablation for
AF should therefore be directed towards creation of complete and lasting
lesion circles.
The Carto3 mapping system allows 3D visualisation of a cardiac chamber by fast
anatomical mapping using intracardiac catheters. During PVI, an outline
(*shell*) of the left atrium is created on which the location of ablation can
be manually annotated.
The new *Visitag* module of the Carto 3D mapping system allows automated
visualization of the precise site of ablation using a grid that is displayed on
the 3D shell of the mapped cardiac chamber. In addition, it shows the amount of
radiofrequency (RF) time for each specific grid point. Displaying the grid may
provide a superior visual feedback for the operator on continuity of ablation
lines and stability of the catheter, compared to single dot visualization by
manual or automatic tagging. As a result it may improve procedure times and
outcomes of catheter ablation of atrial fibrillation.
Study objective
To study the effect of grid visualization during PVI on procedure times, to
study the effect of grid visualization on acquiring direct isolation after
encircling the pulmonary veins (*single round* ), to study the effect of grid
visualization on the 12 month freedom of atrial fibrillation after pulmonary
vein isolation, to study Visitag settings that are associated with single round
PVI
Study design
This is a single-center randomized prospective intervention study.
Intervention
Patients will be randomized to either encircling pulmonary veins using the
automated point-by-point annotation (ablation index) or encircling pulmonary
veins using the grid annotation.
Study burden and risks
All patients will receive standard of medical care for PVI including cardiac CT
or MRI at baseline and transthoracic echocardiography (TTE), and Holter
monitoring at follow-up.
This study is designed to study techniques in PVI of which future patients may
benefit.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
All patients (> 18 years) eligible for pulmonary vein isolation according to ESC (European Society of Cardiology) guidelines.
Exclusion criteria
Unwilling or unable to give written informed consent
Prior left atrial ablation or left atrial flutters
Prior left atrial surgery
Hyperthyroidism (treated hyperthyroidism in euthyriodic state is not an exclusion criterion)
Untreated or uncontrolled hypertension (systolic RR > 160 mmHg)
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL63859.029.18 |
| OMON | NL-OMON25776 |