Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium (PFALCO Remap)

March 5, 2024 updated by: Daniel Mol, Onze Lieve Vrouwe Gasthuis

This study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins.

The main question it aims to answer is: In which percentage of the patients will pulsed field ablation result in successful isolation of the left common ostium?

Nineteen patients will be prospectively included in OLVG. All patients will be treated with pulsed-field ablation (routine care). After the ablation procedure, an electro-anatomical map will be created using the ablation catheter and a mapping system. This map will display the left atrium and the lesion in detail.

After the procedure, three experienced operators are asked to draw a line around the LCO in the anatomical map where they would have ablated if conventional radiofrequency ablation was used. The distance between the drawn line and the ablation lesion will be measured at three predefined points. The lesion is considered successful if the mean distance is within ±10mm at all measurement points.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation (AF) is the most common arrhythmia affecting millions worldwide with increasing prevalence. Patients with AF tend to have more comorbidity and an increased stroke and mortality risk. Pulmonary vein isolation (PVI) has become the cornerstone in the invasive treatment of atrial fibrillation (AF). It has been shown that PVI is more effective in maintaining sinus rhythm and improving quality of life compared to antiarrhythmic drugs. Although PVI results in a 98% burden reduction, an AF recurrence is observed in about half of the patients. AF type, comorbidity, and anatomical pulmonary vein variants affect arrhythmia-free survival.

Eighteen per cent of the patients undergoing PVI have a left common ostium (LCO) of the pulmonary veins.(16) A large ostium characterises an LCO, and single-shot devices tend to have worse arrhythmia-free survival than conventional radiofrequency (C-RF) ablation. A proper pulmonary vein occlusion is crucial during cryoballoon ablation. A large ostium can form a distal lesion with the possibility of pulmonary vein potentials proximal to the lesion resulting in AF recurrence. Wide antrum isolation has been shown to improve outcomes, and a distally located lesion can explain the higher AF recurrence rate.(18)

Farapulse (Boston Scientific, MA, US) pulsed-field ablation (PFA) was recently introduced. PFA uses short pulses of high voltages to achieve electroporation and irreversible cell membrane damage.(19) This technique is tissue-specific and limits collateral damage. While PV reconnection has been observed in 47% of patients who underwent cryoballoon or radiofrequency ablation, PFA ablation creates durable lesions in 86% of patients.(19, 20)

Tissue contact is less critical during PFA than conventional RF or cryoballoon ablation. Therefore one could hypothesise that, in patients with an LCO, PFA can be performed at the actual pulmonary vein ostium and that the lesion location is comparable to conventional RF ablation. Reddy et al. included patients with an LCO and presented an electro-anatomical map showing antral isolation. However, it is still being determined how many patients with an LCO were included, and a comprehensive description of the lesion still needs to be provided. Because no studies investigated the lesion characteristic in patients with AF and an LCO after PFA ablation, this study is designed to examine the lesion location in detail with an electro-anatomical map.

This single-centre study will be conducted prospectively in OLVG, Amsterdam, the Netherlands. Patients are eligible for this study if they are admitted for AF ablation because of symptomatic and drug-resistant/intolerant AF and have an LCO (identified by computer tomography (CT) or magnetic resonance imaging (MRI)). All inclusion and exclusion criteria are described in the paragraph ELIGIBILITY.

The operator will map the left atrial voltage in nineteen patients using the Ensite Precision (Abbott inc. IL, US) and the Farawave ablation catheter. First, all patients will be treated with pulsed-field ablation (routine care). Then, when all pulmonary veins are considered isolated, an electro-atomical map of the left atrium will be created.

After the procedure, three experienced operators are asked to draw a line in the anatomical map where they would have performed ablation if C-RF had been used - again, blinded for voltage. Next, the investigators will measure the distance between the line the operators drew and the ablation lesion at three points. The lesion is considered within range if the mean difference is ±10mm at all measurement points.

All study outcomes are specified in the paragraph OUTCOME MEASURES.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniel Mol, PhD
  • Phone Number: 0031624396610
  • Email: d.mol@olvg.nl

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1091AC
        • OLVG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with atrial fibrillation and a common ostium of the left pulmonary veins admitted and accepted for pulsed-field ablation at OLVG, Amsterdam, will be enrolled if eligible.

Description

Inclusion Criteria:

  • Age > 18 years of age on the day of enrolment of either sex
  • Willing to the sign informed consent
  • Left atrial volume index measured < 60 ml/m2 within last 12 months
  • Documented atrial fibrillation
  • Admitted and accepted for PVI
  • A left common ostium of the pulmonary veins identified by CT or MRI
  • Accepted to receive general anaesthesia

Exclusion Criteria:

  • Patients aged < 18
  • Body mass index > 35kg/m2
  • Left atrial volume index ≥ 60 ml/m2 within 12 months on MRI or cardiac echo
  • New York Heart Association heart failure class III or IV
  • Myocardial infarction within three months before the procedure
  • Unstable angina pectoris
  • Percutaneous coronary interventions within three months before the procedure
  • Sudden cardiac death event within three months before the procedure
  • A life expectancy of less than one year
  • Presence of an atrial tachycardia other than cavotricuspid isthmus-dependent atrial flutter
  • History of blood clotting or bleeding abnormalities
  • History of a thromboembolic event within six months before the procedure
  • A contraindication to anticoagulant
  • Clinical significant infection
  • Unstable clinical significant medical condition
  • Previous left atrium ablation, except successful accessory pathway ablation
  • Presence of a left appendage closure device
  • Presence of an atrial septum occluder
  • Presence of a prosthetic heart valve
  • Occlusion of the inferior venous tract
  • Enrolment in another study that would interfere with this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful left common ostium isolation after pulsed-field ablation in patients with atrial fibrillation
Time Frame: Within one week after the procedure
The distance between the lesion and the line drawn in the electro-anatomical map by three operators will be measured at three predefined points. The lesion is considered successful if the mean distance is within 10mm at all points.
Within one week after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful isolation at each measuring point
Time Frame: Within one week after the procedure
The mean distance between the lesion and line in the electro-anatomical map for each measuring point. (Superior roof, mid posterior, and inferior)
Within one week after the procedure
Distance between the left and right lesion
Time Frame: Within one week after the procedure
Distance between the left and right lesion measured at the superior roof, mid posterior, and inferior
Within one week after the procedure
Correlation between posterior wall conduction speed and the left and right lesion distance
Time Frame: Within one week after the procedure
Conduction speed at the posterior wall will be measured with an activation map. All the activation data will be collected simultaneously with the electro-anatomical map.
Within one week after the procedure
Safety outcomes within the hospital stay
Time Frame: 24 hours

The occurrence of procedural-related complications, including:

  • Vascular complication (defined as a major or minor vascular complication from the Valve Academic Research Consortium-2)
  • Bleeding complication (defined as Bleeding Academic Research Consortium type 2 or higher)
  • Tamponade, for which an intervention is required
  • Transient phrenic nerve palsy (lasting < 24 hours)
  • Persistent phrenic nerve palsy (lasting ≥ 24 hours)
  • Thromboembolic event
  • Admission for more than 24 hours post-procedure and the reason for prolonged admission.
24 hours
Number of patients with successful same-day discharge
Time Frame: 24 hours
The number of patients who were successfully discharged and data on hospital prolongation will be collected.
24 hours
Interoperator variability of the line drawn in the anatomical map
Time Frame: Within one week after the procedure
The investigators will investigate the variation of the line drawn by three operators
Within one week after the procedure
True pulmonary vein isolation demonstrated with the Boston Farawave and Ensite Precision
Time Frame: During the procedure
Here the investigators will investigate whether all pulmonary veins are isolation based on the information from the electro-anatomical map.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouwe Gasthuis

Collaborators

OLVG

Investigators

  • Principal Investigator: Daniel Mol, PhD, OLVG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

April 2, 2023

First Submitted That Met QC Criteria

April 2, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO.23.038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized data can be shared on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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