Status:
RECRUITING
Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation Recurrent
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed Description
All participating patients are required to provide written (or equivalent) informed consent, indicated by a dated signature of the subject or legal representative. The consent process must comply with...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06199180
Start Date
September 20 2024
End Date
September 1 2028
Last Update
December 10 2024
Active Locations (1)
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1
UMCG
Groningen, Netherlands, 9713GZ