Atrial Fibrillation
Conditions
Brief summary
This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.
Interventions
PROCEDUREConventional CLOSE-guided pulmonary vein isolation
Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall.
PROCEDUREHigh power short duration pulmonary vein isolation
Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall.
Sponsors
AZ Sint-Jan AV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or \<7days) or persistent AF (persistent AF is defined as having an AF episode \>7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial) * Patients willing to sign informed consent
Exclusion criteria
* Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode \>1yr) * Previous ablation for AF * Left atrium antero-posterior diameter \>50 mm (parasternal long axis view, PLAX) * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI. * Left ventricular ejection fraction \<35%. * Cardiac surgery within the previous 90 days. * Expecting cardiac transplantation or other cardiac surgery within 180 days. * Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days. * Documented history of a thromboembolic event within the previous 90 days. * Diagnosed atrial myxoma. * Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment * Women who are pregnant or who plan to become pregnant during the study. * Acute illness or active infection at time of index procedure * Advanced renal insufficiency * Unstable angina. * History of blood clotting or bleeding abnormalities. * Contraindication to anticoagulation. * Life expectancy less than 1 year. * Presence of a condition that precludes vascular access. * Unwilling or unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | Procedure (At time of ablation) | Comparison of the procedural time (in minutes) between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation | Months 4-6 after ablation | Atrial tachyarrhythmia will be monitored by Holter |
| Radiofrequency (RF) ablation time | Procedure (At time of ablation) | Comparison of the RF ablation time (in seconds) between groups |
| Fluoroscopy dose | Procedure (At time of ablation) | Comparison of the fluoroscopy dose (Gy cm²) between groups |
| First pass isolation rate | Procedure (At time of ablation) | Reconnection of the veins after adenosine injection or waiting time |
Countries
Austria, Belgium, Netherlands, Switzerland
Outcome results
None listed