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RECRUITING

NCT06199180

Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA). However, in cases requiring a second PVI for recurrent AF, radiofrequency ablation (RFA) is utilized in nearly 95% of instances post-acquiring a 3D high-density map from the left atrium (LA). Up to 85% of patients experiencing recurrent AF after the initial PVI exhibit pulmonary vein (PV) reconnections, often identified as the cause of AF. PFA has demonstrated its safety and efficiency compared to RFA as a swift technique for performing ablation. Yet, whether PFA or RFA stands out as superior or safer when applied for a second PVI remains unclear, as no randomized controlled trial has investigated this comparison. The proposed REPEAT-AF trial aims to randomize 154 AF patients experiencing recurrent AF after the initial PVI, assigning them in a 1:1 ratio to either RFA or PFA. Each patient will receive an implantable cardiac monitor to precisely detect any AF recurrences.

Official title: Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2024-09-20

Completion Date

2028-09

Last Updated

2024-12-10

Healthy Volunteers

Conditions

Atrial Fibrillation Recurrent

Interventions

DEVICE

pulmonary vein isolation with RFA

Patients randomised to RFA will undergo PVI with point-by-point RFA.

DEVICE

pulmonary vein isolation with PFA

Patients randomised to PFA will undergo PVI with PFA.

Subjects who meet all of the following inclusion criteria at screening will be eligible for enrolment: * Patient had 1 previous PVI with either cryoballoon, RF ablation or PFA * Index PVI occurred within \<5 years prior to enrolment * Documented AF recurrence \>30 seconds * Symptomatic AF * Paroxysmal AF * Age \>18 and \<80 years * Willing and capable to provide informed consent * Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study Subjects who meet ANY of the following exclusion criteria will be excluded from the study: * Persistent AF (by diagnosis of duration \>7 days) * Concomitant/ prior diagnosis for atrial tachycardia (AT) and/or atrial flutter (AFl). Note typical cavotricuspid isthmus dependent flutter is not an exclusion criterium. * Underwent additional ablations outside the pulmonary veins during index AF ablation * AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes * Contraindication to, or unwillingness to use, systematic anticoagulation * Left ventricular ejection fraction (LVEF) \<30% as documented by transthoracic echo (TTE) (within \<3 months prior) * Left atrial volume index \>60 ml/m2 * Clinically significant arrhythmias other than AF * Previous surgery for AF * New York Heart Association (NYHA) Functional Class III or IV * Presence of intramural thrombus, tumour or other abnormality that precludes safe catheter introduction or manipulation * BMI \>35 kg/m2 * Significant or symptomatic hypotension, bradycardia, or chronotropic incompetence * Chronic renal insufficiency of \<15 mL/min/1.73 m2 or any history of renal dialysis, or history of renal transplant * Hemodynamically significant valvular disease * Presence of patent foramen ovale (PFO) or atrial septal defect (ASD) closure device * History of abnormal bleeding and/or clotting disorder * History of rheumatic fever * Severe lung disease, pulmonary hypertension, or any lung disease. Only if involving abnormal blood gases or significant dyspnoea * Clinically significant systemic infection or sepsis * Life expectancy \<1 year * Sensitivity to contrast media not controlled by pre-medication * Any of the following within the 3 months prior to enrolment: * Myocardial infarction * Unstable angina * Percutaneous coronary intervention * Heart failure hospitalization * Stroke or TIA * Significant bleeding * Pericarditis/effusions * Left atrial thrombus * Coronary artery bypass grafting/atriotomy within 6 months prior * Organ or haematologic transplant, or currently being evaluated for an organ transplant * Women who are pregnant or breastfeeding

Locations (1)

UMCG

Groningen, Netherlands