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NCT05908955: SCORE

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

Recruiting now NA Last updated 14 February 2025
What this trial tests

NA trial testing PVI in Atrial Fibrillation in 290 participants. Currently enrolling.

Timeline
17 March 2024
Primary endpoint
30 September 2025
31 December 2025

Quick facts

Lead sponsorChinese Academy of Medical Sciences, Fuwai Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment290
Start date17 March 2024
Primary completion30 September 2025
Estimated completion31 December 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Who can join

Adults 40 to 75, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of PVI

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other Chinese Academy of Medical Sciences, Fuwai Hospital trials

Trials by the same sponsor.

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Data sources for this page

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