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

NCT05805189 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-08

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

  • Maria Cecilia Hospital

    lead OTHER

Principal Investigators

  • Saverio Iacopino, MD · Maria Cecilia Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05805189 on ClinicalTrials.gov