RecruitingNot ApplicableNCT05805189

Prospective Evaluation of Biophysical Parameters as Long-term Predictors of Pulmonary Vein Isolation

Prospective Evaluation of Biophysical Parameters as Long-term Predictors of PVI With Multi-Electrode Radiofrequency Catheter: Comparison Between CARTO Guided and Fluoroscopy Guided Approach (MERCY Study)

Sponsor

Maria Cecilia Hospital

Enrollment

60 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

Current, worldwide assessments of the prevalence of AF estimate that 33 million people are affected by this cardiac arrhythmia. As the most common sustained atrial arrhythmia, AF has a well-established association with systemic embolic events, stroke, heart failure, and increased mortality. Current treatment guidelines and consensus statements for patients with AF suggest that most patients should be first managed with a pharmaceutical drug therapy; however, when a patient becomes drug refractory (intolerant or non-responsive), catheter ablation by PV isolation (PVI) is recommended. The aim of PVI is abolishment of all conducted electrical activity beyond the isolating lesions. The recent NICE guidelines have established that today RF point-by-point ablation is the most cost-effective treatment approach over a lifetime after failure of 1 or more anti-arrhythmic drugs5, but until now a new technology, HELIOSTAR, RF Balloon, has not been included in this cost-effectiveness analysis

Eligibility

Min Age: 18 Years

Inclusion Criteria7

The following criteria must be met for subjects to be eligible for inclusion into the study
Subjects indicated for the treatment of paroxysmal AF with the RF ablation system according to current and future Guidelines and system indications for use
Subjects who are willing and capable of providing informed consent
Patients who have stopped amiodarone for at least one month
Subjects whose age is \> 18 years old
Subjects whose age is \< 80 years old
Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center

Exclusion Criteria14

Subjects who meet any one of the following criteria will be excluded from this clinical study
Patients who had already undergo an AF ablation procedure
Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use
Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use
Presence of an intracavitary thrombus
Subjects that are unable or not willing to complete follow-up visits and examination for the duration of the study
Patients with left ventricular ejection fraction \< 35%
Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion)
Hematological contraindications to ionizing radiation exposure
Presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment
Uncontrolled heart failure
Subjects with severe valvular disease OR with a prosthetic - mechanical or biological- heart valve (not including valve repair and annular rings)
Contraindications to general anesthesia
Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study

Interventions

PROCEDUREpulmonary vein (PV) isolation

The settings used during ablation will be for both groups: 15W, unipolar; 5ml/min baseline irrigation, 35ml/min irrigation during inflation/RF application; 55°C target electrode temperature; RF application time 60s for anterior electrodes, 20s for posterior electrodes. The catheter insertion in Pulmonary vein and ablation workflow will be different for two groups.