The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.
Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes: * Multi-directional high-density mapping * High power - short duration settings * Contact force sensing ablation catheter The aim of LOWE AF HD is to assess the acute safety and success rate of this approach and also the long-term outcome assessed by atrial recurrences arrythmias collected by an implantable loop recorder.
Study Type
OBSERVATIONAL
Enrollment
83
Ospedale San Giovanni Bosco
Napoli, Italy
Acute Procedural Success Rate
Acute procedural success defined as electrical isolation of all pulmonary veins, confirmed by the high-density voltage remap and loss of pace capture along ablation line after complete isolation.
Time frame: 1 day
Rate of patients without Atrial Fibrillation recurrences
Freedom from Atrial Fibrillation (AF) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL), lasting longer than 30 second, assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR).
Time frame: 12 months after 3-months blanking period
Adverse events rate
Procedural and post procedural safety assessed by reporting all adverse events in the first 30 days after ablation
Time frame: 1 month
Ablation Procedure Time
Complete procedure time (minutes)
Time frame: 1 day
Ablation Fluoroscopic Time
Fluoroscopic time recorded (minutes) during ablation procedure
Time frame: 1 day
Number of radiofrequency applications
Number of radiofrequency applications reported for each patient during ablation procedure.
Time frame: 1 day
Total radiofrequency ablation time
Total time (minutes) of radiofrequency applications in each patient during ablation procedure.
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
First pass pulmonary vein isolation
Number of patients in which PV isolation is obtained at first attempt.
Time frame: 1 day
Number of atrial fibrillation events
Number of AF events symptomatic and asymptomatic assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR).
Time frame: 12 months
Atrial Fibrillation Burden
AF Burden (in minutes) recorded at 12 months (after 3-months blanking period) of follow-up by Implantable Loop Recorder.
Time frame: 12 months