Clinical trial NCT05777551: AF Ablation With High Power Short Duration RF
Official title: Atrial Fibrillation Ablation by Means of Very High Power Short Duration (AIR HPSD Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Catheter Ablation
Lead sponsor: Clinica Mediterranea
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with paroxysmal/persistent AF with indication to catheter ablation according to current guidelines

Brief summary: This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF).

Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters).

Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD.

At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R\^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.

Detailed description: Patients will be screened in ambulatory and scheduled for AF ablation according to current guidelines. Ablation will be usually performed under effective oral anticoagulation. Anticoagulation could be withdrawn before admission, so as antiarrhythmic drugs will be removed before scheduled procedure. Patients in AF or with a CHA2DS2-VASc score ≥ 1 will undergo transesophageal echocardiography within 48 hours prior to the ablation. For all other patients transesophageal echocardiography is optional. Cardiac MRI or Cardiac CT scan could be executed as a reference for volume estimations obtained with the mapping system.

Ablation will be carried out under mild or deep sedation, or general anesthesia according to center preference. At least 2 femoral vein access will be obtained and in some patients 1 subclavian vein. One diagnostic catheter will be positioned in the coronary sinus. One or two transseptal accesses to the left atrium will be achieved using a standard approach. Then, the mapping catheter (LASSO, Penta-ray, Octa-ray catheter) and the ablation catheter (QDot Micro catheter) will be placed in the left atrium. Heparin will be administered before the transseptal punctures to maintain an activated clotting time ≥ 300 seconds for the duration of the procedure. Left atrium mapping will be performed in sinus rhythm. Patients with atrial fibrillation at the beginning of the index procedure will undergo electrical cardioversion. After left atrium reconstruction the effective PV-left atrium electrical connection will be checked with the mapping catheter. In all patients a wide antrum circumferential ablation aimed at PV isolation will be performed using the QDot Micro catheter in QMode+ mode (90 w for 4 sec) for the whole ablation or in an hybrid mode (QMode + for posterior wall and QMode guided by AI in the anterior wall), according to the operator preference. The maximum interlesion distance will be \<6 mm (16,17). According to operator preference it will be performed an ablation line encircling each PV or two ablation lines encircling the right and the left PVs. At the end of the ablation effective PV isolation (entry and exit block), will be checked with mapping catheter. After PV isolation will be achieved, the reconnection of the same vein will be evaluated after a 20 minute period from the initial isolation or after adenosine infusion or isoproterenol. If the vein reconnects to the atrium, the ablation will be directed to the gaps identified by the mapping catheter.

All patients will undergo a post-procedural ECG and, optional, an echocardiogram to exclude pericardial effusion or other acute complications.

After ablation, patients will undertake regular follow-up assessments (scheduled at 3 months) including a detailed history, physical examination, 12-lead standard electrocardiography, and 24-h Holter monitoring. Patients who will not report any symptoms related to the previous arrhythmia during a supplementary detailed follow up (6-12 months subsequent to catheter ablation) will be considered free of arrhythmia recurrence

Eligibility criteria: Inclusion Criteria:

* Patients with paroxysmal/persistent AF who signed the informed consent
* Patients on active oral anticoagulation

Exclusion Criteria:

* Previous ablation for AF
* Patients with LVEF\<35%
* Women potentially pregnant
* Contraindications to X-ray exposure
* Congenital heart disease or cardiac surgery within 1 month

Primary outcomes:
measure: Association between clinical and procedural characteristics and the percentage of arrhythmia recurrence rate after PV isolation performed with HPSD.
timeFrame: 12 months after ablation
Secondary outcomes:
measure: Percentage of acute pulmonary vein reconnection reconnection
timeFrame: 20 minutes after ablation
measure: Procedural time
timeFrame: during the procedure
measure: Percentage of patients with atrial arrhythmias recurrence during the blanking period
timeFrame: 3 months after ablation
measure: Impact of anaesthesia type
timeFrame: during the procedure
measure: Evaluation of pain perception during ablation
timeFrame: during the procedure
measure: Fluoroscopy time
timeFrame: during the procedure
measure: Radiofrequency time
timeFrame: during the procedure
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 30 days and 12 months after ablation
Locations:
city: Paris
country: France
facility: Centre Cardiologique Du Nord
city: Mercogliano
country: Italy
facility: Clinica Montevergine
state: AV
city: Cotignola
country: Italy
facility: Maria cecilia Hospital
state: RA
city: Conegliano
country: Italy
facility: Ospedale di Conegliano
state: TV
city: Ancona
country: Italy
facility: Università Politecnica delle Marche
city: Asti
country: Italy
facility: Ospedale Civile di Asti
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Torino
country: Italy
facility: Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
Study officials:
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