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

Maria Cecilia Hospital

Status

Enrolling

Conditions

Atrial Fibrillation

Treatments

Procedure: pulmonary vein (PV) isolation

Study type

Interventional

Funder types

Other

Identifiers

NCT05805189

MERCY

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

60 participants in 2 patient groups

Heliostar group A

Experimental group

Description:

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

Treatment:

Procedure: pulmonary vein (PV) isolation

Carto Group B

Active Comparator group

Description:

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

Treatment:

Procedure: pulmonary vein (PV) isolation