RecruitingNot ApplicableNCT06199180

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

Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat

Sponsor

University Medical Center Groningen

Enrollment

154 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Recurrent

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

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

Exclusion Criteria34

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