Improving Atrial Fibrillation Treatment with New Ablation Techniques
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
This study is testing if a new way of treating paroxysmal atrial fibrillation by combining two techniques can help patients feel better and stay safe compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05908955 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of combining quantitative superior vena cava isolation (SVCI) with pulmonary vein isolation (PVI) for patients suffering from paroxysmal atrial fibrillation (PAF). Participants will be randomly assigned to receive either standard PVI or PVI plus quantitative SVCI, with a follow-up period of 12 months to assess outcomes. The study aims to establish a standardized ablation procedure that minimizes risks while maximizing efficacy through the use of a quantitative ablation index. By addressing the limitations of previous SVCI studies, this trial seeks to provide clearer insights into the potential benefits of this combined approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-75 with symptomatic paroxysmal atrial fibrillation unresponsive to antiarrhythmic drugs.
Not a fit: Patients with a history of catheter ablation, thoracic surgery, or significant heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with paroxysmal atrial fibrillation.
How similar studies have performed: Previous studies on superior vena cava isolation have shown mixed results, making this approach both novel and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Chinese Academy of Medical Science, Fuwai hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jun Liu, MD, PhD — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Wenchi Guan, MD, PhD
- Email: wenchi.guan@outlook.com
- Phone: +8613521270747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.