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ACTIVE NOT RECRUITING
NCT05805189
NA

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

Sponsor: Maria Cecilia Hospital

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-02-09

Completion Date

2026-09-30

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

PROCEDURE

pulmonary 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.

Locations (1)

Maria Cecilia Hospital

Cotignola, Ravenna, Italy