Atrial Fibrillation
Conditions
Brief summary
In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).
Detailed description
BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) \>550 and \>400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown. OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF. POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.
Interventions
PROCEDUREHigh power CLOSE-guided PVI ablation
CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
PROCEDUREStandard CLOSE-guided PVI ablation
Standard AF ablation according to the CLOSE-protocol
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
* All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease * Signed Patient Informed Consent Form * Age 18 years or older * Able and willing to comply with all follow-up testing and requirements
Exclusion criteria
* Persistent atrial fibrillation (history of AF\>7days or history of cardioversion \> 48h of AF) * Previous ablation for AF * LA antero-posterior diameter\>50 mm (parasternal long axis view , PLAX) * LVEF \<35% (ejection fraction) * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * CABG procedure within the last three months * Awaiting cardiac transplantation or other cardiac surgery * Documented left atrial thrombus on imaging * Diagnosed atrial myxoma * Women who are pregnant or breastfeeding * Acute illness or active systemic infection or sepsis * Unstable angina * Uncontrolled heart failure * Myocardial infarction within the previous two months * History of blood clotting or bleeding abnormalities * Contraindication to anticoagulation therapy (ie, heparin or warfarin) * Life expectancy less than 12 months * Enrollment in any other study evaluating another device or drug * Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Acute procedural success | At time of ablation | First pass pulmonary vein isolation confirmed after adenosine injection |
| Safety: Absence of clinical complications | From time of ablation to 1 month post procedure | Absence of clinical complications during the procedure and up to one month thereafter |
Secondary
| Measure | Time frame |
|---|---|
| Fluoroscopic duration and irradiation (AK) | At time of ablation |
| Amount of ablation points associated with temperature rise | At time of ablation |
| Maximum temperature in case of temperature rise | At time of ablation |
| Incidence of adverse events related to ablation | From time of ablation to 6 months post procedure |
| First pass encirclement isolation rate | At time of ablation |
| Procedural duration time | At time of ablation |
| Number of dislocations | At time of ablation |
| Number of ablation points with an oesophageal temperature rise >39°C | At time of ablation |
| Maximum temperature in case of oesophageal temperature rise | At time of ablation |
| Longterm procedural success rate | Six months after ablation |
| Reconnection rate after adenosine | At time of ablation |
| Duration for pulmonary vein isolation | At time of ablation |
Countries
Belgium
Outcome results
None listed