An observational study in Atrial Fibrillation, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational
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 of patients with PAF. However, results from previous studies about SVCI remain controversial. Safety concerns for SVCI may 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. Therefore, the investigators sought to initiate a retrospective, multi-center study, to explore the efficacy and safety of quantitative SVCI in addition to PVI in PAF.
Catheter ablation has emerged as an effective treatment for drug-refractory PAF and is recommended as first-line therapy by current guidelines. PVI is considered the cornerstone of catheter ablation for atrial fibrillation (AF). However, despite persistent PVI, a subgroup of patients may experience recurrent AF due to focal ectopic discharges originating outside the pulmonary veins. Among the non-pulmonary vein triggers, the SVC stands out as a common culprit, making it a promising ablation target for maintaining sinus rhythm. Nevertheless, results from previous studies that evaluated the efficacy of SVCI showed conflicting results. One possible explanation is that SVC is adjacent to critical anatomical structures (such as the sinus node and the phrenic nerve), which raises safety concerns and often leads to inadequate ablation.
Therefore, it is necessary to establish a standardized ablation procedure for SVCI, ensuring both safety and efficacy. To address this issue, the investigators proposed the concept of "quantitative ablation for SVCI." By introducing AI as a quantitative measure, it is possible to achieve precise catheter ablation while minimizing the risk of procedure-related complications.
This study aimed to investigate the safety and feasibility of quantitative AI-guided SVCI in addition to PVI. Participants with PAF who required catheter ablation will be consecutively enrolled in three hospitals in China.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 400 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).
Exclusion Criteria:
Procedure: Pulmonary vein isolation plus superior vena cava isolation
Procedure: Pulmonary vein isolation
Pulmonary vein isolation plus superior vena cava isolation
Pulmonary vein isolation only
AT/AF recurrence
atrial fibrillation, atrial flutter, atrial tachycardia over 30s
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital