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Clinical Trials in Italy / NCT05805189
Active, not recruiting Not applicable

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

NCT05805189 · tracked via the Priya Life Science Italy tracker
Sponsor
Maria Cecilia Hospital
Phase
Not applicable
Started
2023-02-09
Last updated
2026-05-08

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

pulmonary vein (PV) isolation

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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: 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

Primary outcome measure(s)

  • Pulmonary vein single shot isolation — 12 months
    The primary objective of this study is PV single shot isolation in acute and at 1-3-6-12 months follow up with stringent monitoring including medical examination (Echo, ECG, and 24h-Holter).. It will be assessed the time necessary to reach the isolation, the number of erogations, the fluoroscopy dose and any use of contrast medium and they will be compared between the two arms. Our aim is to demonstrate that, even in the case of equivalent relapse rates during the follow up, the CARTO guided approach allows patients to benefit from a faster and less invasive procedure compared to the fluoroscopy guided method. This occurs because the former doesn't require contrast medium and the fluoroscopy time is notably reduced.

Trial sites (1)

FacilityCityRegionStatus
Maria Cecilia Hospital Cotignola Ravenna

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Other trials for the same condition

The Fourth Left Atrial Appendage Occlusion Study Recruiting
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing Recruiting
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI) Recruiting
Pericardiotomy in Cardiac Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05805189 on ClinicalTrials.gov ↗ ← All trials in Italy