RecruitingNot ApplicableNCT05908955

Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Efficacy and Safety of Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: the SCORE Randomized Controlled Trial


Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Enrollment

290 participants

Start Date

Mar 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding isolation of the superior vena cava (a large vein near the heart that can trigger abnormal rhythms) to standard pulmonary vein isolation improves outcomes for people with paroxysmal atrial fibrillation (a type of irregular heartbeat that comes and goes) undergoing catheter ablation. **You may be eligible if...** - You are 40–75 years old - You have atrial fibrillation that comes and goes (paroxysmal AF) with symptoms - Your AF has not responded to one or more anti-arrhythmic medications - You are willing to undergo catheter ablation (a minimally invasive heart procedure) **You may NOT be eligible if...** - You have had a previous catheter ablation or heart surgery of any kind - You have a history of cancer - You have a permanent pacemaker - You have significant heart failure (ejection fraction below 40% or severe symptoms) - You have a sinus node problem - You are allergic to contrast dye - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPVI

pulmonary vein isolation

PROCEDUREPVI+ quantitative SVCI

pulmonary vein isolation and superior vena cava isolation guided by quantitative ablation index


Locations(1)

Chinese Academy of Medical Science, Fuwai hospital

Beijing, Beijing Municipality, China

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NCT05908955


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