Superior Vena Cava Isolation Plus Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

NCT06183619 | Active Not Recruiting

• 1 other identifier: T2020-ZX019
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• AT/AF recurrence

  atrial fibrillation, atrial flutter, atrial tachycardia over 30s

  12 months

Study Arms (2)

Pulmonary vein isolation plus superior vena cava isolation

Procedure: Pulmonary vein isolation plus superior vena cava isolation

Pulmonary vein isolation

Procedure: Pulmonary vein isolation

Interventions

Pulmonary vein isolation plus superior vena cava isolation PROCEDURE

Pulmonary vein isolation plus superior vena cava isolation

Pulmonary vein isolation plus superior vena cava isolation

Pulmonary vein isolation PROCEDURE

Pulmonary vein isolation only

Pulmonary vein isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).

You may qualify if:

• Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).
• Willing to undergo catheter ablation for AF.

You may not qualify if:

• History of any type of catheter ablation for cardiac arrhythmias.
• Sinus node dysfunction that requires permanent pacemaker implantation.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Chinese Academy of Medical Science, Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Liu, MD, PhD

  Fuwai hospital, Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 27, 2023
• Study Start: February 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: May 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)