Actively Recruiting
Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF
Led by University Medical Center Groningen · Updated on 2024-12-10
154
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Persistent AF (duration >7 days)
- Concomitant or prior diagnosis of atrial tachycardia or atrial flutter (except typical cavotricuspid isthmus dependent flutter)
- Additional ablations outside pulmonary veins during index AF ablation
- AF caused by electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Contraindication to or unwillingness to use systematic anticoagulation
- Left ventricular ejection fraction <30% by transthoracic echo 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 Functional Class III or IV
- Presence of intramural thrombus, tumor, or other abnormality preventing safe catheter use
- Body mass index >35 kg/m2
- Significant or symptomatic hypotension, bradycardia, or chronotropic incompetence
- Chronic renal insufficiency with <15 mL/min/1.73 m2 or history of dialysis or renal transplant
- Hemodynamically significant valvular disease
- Presence of patent foramen ovale or atrial septal defect closure device
- History of abnormal bleeding or clotting disorder
- History of rheumatic fever
- Severe lung disease, pulmonary hypertension, or lung disease with abnormal blood gases or significant dyspnea
- Clinically significant systemic infection or sepsis
- Life expectancy less than 1 year
- Sensitivity to contrast media not controlled by pre-medication
- Within 3 months prior: myocardial infarction, unstable angina, percutaneous coronary intervention, heart failure hospitalization, stroke or TIA, significant bleeding, pericarditis/effusions, left atrial thrombus
- Coronary artery bypass grafting or atriotomy within 6 months prior
- Organ or hematologic transplant or evaluation for transplant
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UMCG
Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
Y
Yuri Blaauw, Dr.
CONTACT
N
Nick van Vreeswijk, drs.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here