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

NCT ID: NCT05805189

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2025-06-30

Brief 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

Detailed Description

The multi-electrode RF Balloon catheter (HELIOSTAR, Biosense Webster) is a compliant Balloon with 10 circularly orientated electrodes bonded to its surface. It has been designed to be used in conjunction with the Carto3 system (Biosense Webster, CA). It is able to deliver RF energy directly forming a continuous circular ablation lesion around the PV ostia. With HELIOSTAR, each individual electrode can sense temperature and can be controlled separately. The electrodes can be used for visualization, stimulation, recording and ablation. The compliance of the Balloon allows conformation to the anatomy of the PVs and therefore maximizing tissue contact. The advantages of the RF Balloon include the ease of use to the operator that is associated with Balloon delivery systems, possibility of single shot PVI with tailored RF energy delivery, potentially shorter procedure times and avoidance of collateral damage to non-PVI structures, due to the capacity to individually select and deselect electrodes during ablation.6,7 To date, retrospective analyzes conducted in the RADIANCE and SHINE studies have shown the pre-ablation indicators of optimal electrode positioning and post-RF indicators associated with better outcomes; specifically, baseline impedance range 90-110 Ohms, impedance variability across ten electrodes ≤20 Ohms, baseline electrode temperature ≤31°C, baseline temperature variability ≤3°C and the post-RF indicators (impedance drop ≥12 Ohm and temperature rise ≥6°C) seem to independently predict a durable PVI. To the best of our knowledge, no studies have investigated prospectively the performance of impedance drop and temperature rise of HELIOSTAR ablation in terms of feasibility, acute PVI and post-procedural outcomes.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Heliostar group A

In this group the achievement of isolation of the pulmonary veins is evaluated with one shot tecnology Heliostar, multielecrode radiofrequency ballon catheter guided by the impedance level measured in the veins

Group Type: EXPERIMENTAL

pulmonary vein (PV) isolation

Intervention Type: PROCEDURE

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.

Carto Group B

In this group the achievement of isolation of the pulmonary veins is evaluated with classic method guided by fluoroscopy

Group Type: ACTIVE_COMPARATOR

pulmonary vein (PV) isolation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Cecilia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saverio Iacopino, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Cecilia Hospital

Locations

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Saverio Iacopino, MD

Role: CONTACT

siacopino@gvmnet.it

0545/217228 ext. +39

Filippo Placentino, MSc

Role: CONTACT

Facility Contacts

Saverio Iacopino, MD

Role: primary

siacopino@gvmnet.it

0545/217228

Other Identifiers

MERCY

Identifier Type: -

Identifier Source: org_study_id