protocolSection identificationModule nctId: NCT06334250, orgStudyIdInfo id: IRAS:327077, briefTitle: Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial, acronym: PLANET-AF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Liverpool Heart and Chest Hospital NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk. In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming. There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting. Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. In this randomised controlled trial, patients referred for LAAO will be randomised to receive LAAO+PFA (intervention) or LAAO alone (control). Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Catheter ablation of atrial fibrillation using Pulsed Field Ablation, interventions name: Left atrial appendage occlusion, outcomesModule primaryOutcomes measure: Change in quality of lfie, secondaryOutcomes measure: Time to atrial fibrillation recurrence, secondaryOutcomes measure: Requirement for unplanned further ablation or cardioversion procedures, secondaryOutcomes measure: Procedural metrics, secondaryOutcomes measure: Procedural safety outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Liverpool Heart and Chest Hospital, city: Liverpool, state: Merseyside, zip: L14 3PE, country: United Kingdom, contacts name: Mark Mills, role: CONTACT, phone: +441516001616, email: mark.mills@lhch.nhs.uk, geoPoint lat: 53.41058, lon: -2.97794, hasResults: False