An interventional study of High power CLOSE-guided PVI ablation and Standard CLOSE-guided PVI ablation in Atrial Fibrillation, sponsored by AZ Sint-Jan AV. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-12.
Sponsored by AZ Sint-Jan AV · Not applicable, Interventional, and Treatment
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).
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.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 100 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).
Procedure: High power CLOSE-guided PVI ablation
The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)
Procedure: Standard CLOSE-guided PVI ablation
CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
Standard AF ablation according to the CLOSE-protocol
Efficacy: Acute procedural success
First pass pulmonary vein isolation confirmed after adenosine injection
Time frame: At time of ablation
Safety: Absence of clinical complications
Absence of clinical complications during the procedure and up to one month thereafter
Time frame: From time of ablation to 1 month post procedure
Procedural duration time
Time frame: At time of ablation
Duration for pulmonary vein isolation
Time frame: At time of ablation
Fluoroscopic duration and irradiation (AK)
Time frame: At time of ablation
Amount of ablation points associated with temperature rise
Time frame: At time of ablation
Maximum temperature in case of temperature rise
Time frame: At time of ablation
Incidence of adverse events related to ablation
Time frame: From time of ablation to 6 months post procedure
First pass encirclement isolation rate
Time frame: At time of ablation
Reconnection rate after adenosine
Time frame: At time of ablation
Number of dislocations
Time frame: At time of ablation
Number of ablation points with an oesophageal temperature rise >39°C
Time frame: At time of ablation
Maximum temperature in case of oesophageal temperature rise
Time frame: At time of ablation
Longterm procedural success rate
Time frame: Six months after ablation
Plan to share: Undecided
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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AZ Sint-Jan AV