NCT05908955Recruiting
Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- First submitted
- 8 Jun 2023
- Start date
- Mar 2024
- Primary completion date
- Sept 2025
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05908955
What you commit to
- Study type: Interventional
- Planned participants: 290
- From Mar 2024 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Allergy to contrast agents.
Lab values
- Heart failure (left ventricular ejection fraction ≤40% or NYHA class III\~IV).
Age
- Age: \<40yrs or \>75yrs.
Other
- Peripherally inserted central catheter for long-term
- Sinus node dysfunction
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Science, Fuwai hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.