NCT05908955 Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
| NCT ID | NCT05908955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2024-03-17 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 290 participants in total. It began in 2024-03-17 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * History of any type of catheter ablation for cardiac arrhythmias. * History of any type of thoracic surgery, including cardiac surgery. * History of malignant tumors. * History of permanent pacemaker implantation. * Peripherally inserted central catheter for long-term * Heart failure (left ventricular ejection fraction ≤40% or NYHA class III\~IV). * Sinus node dysfunction * Allergy to contrast agents. * Pregnancy or lactation. * Age: \<40yrs or \>75yrs.
Contact & Investigator
Jun Liu, MD, PhD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT05908955 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05908955 currently recruiting?
Yes, NCT05908955 is actively recruiting participants. Contact the research team at wenchi.guan@outlook.com for enrollment information.
Where is the NCT05908955 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05908955 clinical trial?
NCT05908955 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The principal investigator is Jun Liu, MD, PhD at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 290 participants.
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