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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).

• Willing to undergo catheter ablation for AF.

• Age: 40-75 years old.

Locations
Other Locations
China
Chinese Academy of Medical Science, Fuwai hospital
RECRUITING
Beijing
Contact Information
Primary
Wenchi Guan, MD, PhD
wenchi.guan@outlook.com
+8613521270747
Backup
Jun Liu, MD, PhD
liujundoctor@163.com
+8615810319596
Time Frame
Start Date: 2024-03-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 290
Treatments
Active_comparator: PVI
Participants in this group will receive pulmonary vein isolation.
Experimental: PVI+SVCI
Participants in this group will receive superior vena cava isolation in addition to pulmonary vein isolation.
Related Therapeutic Areas
Sponsors
Leads: Chinese Academy of Medical Sciences, Fuwai Hospital

This content was sourced from clinicaltrials.gov