Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation (SCORE)

February 12, 2025 updated by: Jun Liu,MD, Chinese Academy of Medical Sciences, Fuwai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 evaluate the efficacy of SVCI showed conflicting results. One possible explanation is that SVC is adjacent to critical anatomy 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 standardized ablation procedure for SVCI, ensuring both safety and efficacy. To address this issue, we 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.

The SCORE trial is single-center, prospective, randomized controlled trial aiming to enroll 290 patients with 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 goal is to determine whether quantitative SVCI could improve clinical results for PAF when added to PVI. The key objectives are as follows:

  1. Evaluate the efficacy of PVI+SVCI guided by quantitative AI.
  2. Assess the safety of PVI+SVCI guided by quantitative AI.

The primary endpoint of the study is treatment success, defined as freedom from AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds, at the 3-month follow-up. Secondary endpoints include treatment success at the 12-month follow-up and safety outcomes, including death, stroke/TIA, pericardial tamponade or effusion requiring drainage, pulmonary vein stenosis, superior vena cava stenosis, diaphragmatic nerve injury or paralysis, sinus node dysfunction, and atrial esophageal fistula.

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100051
        • Recruiting
        • Chinese Academy of Medical Science, Fuwai hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PVI
Participants in this group will receive pulmonary vein isolation.
Procedure: PVI
pulmonary vein isolation
Experimental: PVI+SVCI
Participants in this group will receive superior vena cava isolation in addition to pulmonary vein isolation.
Procedure: PVI+ quantitative SVCI
pulmonary vein isolation and superior vena cava isolation guided by quantitative ablation index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 3 months follow-up
Time Frame: 3 months
The proportion of patients that are freedom from AF, atrial flutter, or atrial tachycardia for longer than 30 seconds measured by 14-day Holter ECG at 3 months after the index ablation.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 12 months follow-up
Time Frame: 12 months
The proportion of patients that are freedom from AF, atrial flutter, or atrial tachycardia for longer than 30 seconds measured by 14-day Holter ECG at 12 months after the index ablation.
12 months
Incidence of treatment emergent adverse events post ablation
Time Frame: 12 months
Incidence of treatment emergent adverse events that include death, stroke/TIA, pericardial tamponade or effusion that requires drainage, pulmonary vein stenosis, superior vena cava stenosis, diaphragmatic nerve injury or paralysis, sinus node dysfunction, and atrial esophageal fistula.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: Jun Liu, MD, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-GSP-GG-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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