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

NCT05805189 | Recruiting

• 1 other identifier: MERCY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Pulmonary vein single shot isolation

  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.

  12 months

Secondary Outcomes (1)

• Correlation of biophysical parameters, procedural, and ablation times

  12 months

Study Arms (2)

Heliostar group A

EXPERIMENTAL

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

Procedure: pulmonary vein (PV) isolation

Carto Group B

ACTIVE COMPARATOR

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

Procedure: pulmonary vein (PV) isolation

Interventions

pulmonary vein (PV) isolation 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; Heliostar group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saverio Iacopino, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saverio Iacopino, MD

CONTACT

0545/217228; siacopino@gvmnet.it

Filippo Placentino, MSc

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, randomized study, designed to evaluate the acute achievement of pulmonary vein isolation with HELIOSTAR Balloon catheter. In this study, patients will be treat using prospectively the pre-ablation indicators of optimal electrode positioning in comparison with standard positioning evaluated by fluoroscopy visualization and contrast injection and the optimized biophysical parameters as predictors of long-term efficacy.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 7, 2023
• Study Start: February 9, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)