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

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether measurements taken during a heart ablation procedure (radiofrequency ablation to treat irregular heartbeat called atrial fibrillation) can predict which patients will have a successful long-term outcome — potentially helping doctors personalize future AF treatment. **You may be eligible if:** - You are between 18 and 80 years old - You have paroxysmal atrial fibrillation (AF that comes and goes) for which your doctor has recommended ablation - You have not previously had an AF ablation procedure - You have stopped amiodarone (a heart rhythm drug) for at least one month before the procedure - You are willing and able to attend all follow-up visits **You may NOT be eligible if:** - You have already had an AF ablation - You have a blood clot in your heart - You have very poor heart function (ejection fraction below 35%) - You are pregnant or planning to become pregnant during the study - You have certain blood conditions that make radiation exposure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.