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NCT Number: NCT06497933

Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter

Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Rouen

Rouen, 76000, France

About this study

This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France.

All patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33.

A one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years
  • Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.

Exclusion criteria

  • Previous left atrial ablation.
  • Patient's opposition to participating in this registry

Treatment and study plan

Atrial fibrillation ablation

Procedure

Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter

Other names: Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)

Primary outcomes

  1. long-term efficacy (AA)

    Time frame: within 1-year period post-procedure

    freedom from all types of atrial arrhythmia recurrences

  2. very long-term efficacy (AA)

    Time frame: Within 2 years period post-procedure

    freedom from all types of atrial arrhythmia recurrences

Secondary outcomes

  1. long term efficacy (AF)

    Time frame: within 1-year period post-procedure

    freedom from atrial fibrillation recurrences

  2. very long-term efficacy (AF)

    Time frame: Within 2 years period post-procedure

    freedom from atrial fibrillation recurrences

  3. Safety outcomes

    Time frame: within 1-month post-procedure

    the composite of major adverse events, including esophageal complications, symptomatic PV stenosis, cardiac tamponade requiring intervention, stroke or systemic thromboembolism, persistent phrenic nerve injury, vascular access complications requiring surgery, coronary artery spasm, and death

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter

Acronym: FRANCE-PFA

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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