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…
ID
Bron
Verkorte titel
Aandoening
Atrial Fibrillation, atriumfibrilleren, boezemfibrilleren
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Procedure time
Achtergrond van het onderzoek
Randomized prospective intervention study, comparing grid visualization to point-by-point visualization of ablation lesions during pulmonary vein isolation.
Doel van het onderzoek
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 Carto 3D 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.
Onderzoeksopzet
1 year - freedom from atrial fibrillation
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients (> 18 years) eligible for PVI according to ESC guidelines.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Unwilling or unable to give written informed consent
Prior left atrial surgery
Hyperthyroidism (treated hyperthyroidism in euthyriodic state is not an exclusion criterion)
Untreated or uncontrolled hypertension (systolic RR > 160 mmHg)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7162 |
NTR-old | NTR7361 |
CCMO | NL63859.029.18 |
OMON | NL-OMON46613 |