AF Ablation With High Power Short Duration RF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorClinica Mediterranea
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with paroxysmal/persistent AF who signed the informed consent
Patients on active oral anticoagulation
Disqualifiers
Previous ablation for AF
Patients with LVEF<35%
Women potentially pregnant
Contraindications to X-ray exposure
Trial population
Patients with paroxysmal/persistent AF with indication to catheter ablation according to current guidelines
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Association between clinical and procedural characteristics and the percentage of arrhythmia recurrence rate after PV isolation performed with HPSD.
to assess the efficacy of the procedure in terms of atrial arrhythmia recurrence-free rate (binary outcome), with a number of candidate predictors equal to 10
Time frame
12 months after ablationSecondary outcomes
1
Percentage of acute pulmonary vein reconnection reconnection
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.
Time frame
20 minutes after ablation2
Procedural time
The Investigators will calculate the overall procedural time (min)
Time frame
during the procedure3
Percentage of patients with atrial arrhythmias recurrence during the blanking period
Number of patients with an atrial arrhythmia (atrial fibrillation, atrial tachycardia, atrial flutter) episode lasting at least 30 sec during the 3 month blanking period after the index ablation
Time frame
3 months after ablation4
Impact of anaesthesia type
The Investigators will evaluate the type of anesthesia: (mild sedation, deep sedation, general anesthesia), the anesthetic drugs used and their dose in mg
Time frame
during the procedureOther outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events, acute and at 30-day and 12-month as assessed by CTCAE v4.0
Time frame
30 days and 12 months after ablationSponsors and contacts
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Source ClinicalTrials.gov