Actively Recruiting
Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Led by Chinese Academy of Medical Sciences, Fuwai Hospital · Updated on 2025-02-14
290
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) has limited success. The superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein triggers for PAF. It is estimated that SVC isolation (SVCI) could improve the clinical results for patients with PAF. However, results from previous studies about SVCI remain controversial. It is possible that safety concerns for SVCI outweigh its benefits and lead to inadequate ablation. To address this issue, the introduction of a quantitative ablation index (AI) for SVCI may provide a solution. The goal of this prospective, randomized controlled trial is to test the efficacy and safety of quantitative SVCI in addition to PVI in PAF. Participants with PAF will be randomly assigned to either PVI group or PVI+ quantitative SVCI group in a 1:1 ratio and will be followed up for 12 months. The main questions it aims to answer are: 1. Evaluate the efficacy of PVI+SVCI guided by quantitative AI. 2. Assess the safety of PVI+SVCI guided by quantitative AI. The primary end point is treatment success at 3 months after the index ablation. The secondary end points include treatment success at 12 months, and safety outcomes.
CONDITIONS
Official Title
Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic paroxysmal atrial fibrillation not responding to one or more antiarrhythmic drugs
- Willing to have catheter ablation for atrial fibrillation
- Age between 40 and 75 years old
You will not qualify if you...
- Previous catheter ablation for any heart rhythm disorder
- History of any thoracic surgery including heart surgery
- History of cancer
- Permanent pacemaker implanted
- Long-term use of peripherally inserted central catheter
- Heart failure with left ventricular ejection fraction 40% or less or New York Heart Association class III or IV
- Sinus node dysfunction
- Allergy to contrast dye
- Pregnancy or breastfeeding
- Age younger than 40 or older than 75 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science, Fuwai hospital
Beijing, Beijing Municipality, China, 100051
Actively Recruiting
Research Team
W
Wenchi Guan, MD, PhD
CONTACT
J
Jun Liu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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