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

NCT05908955 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2025-02-14

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

PVI

pulmonary vein isolation

PROCEDURE

PVI+ quantitative SVCI

pulmonary vein isolation and superior vena cava isolation guided by quantitative ablation index

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Jun Liu, MD, PhD · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-17
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908955 on ClinicalTrials.gov