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SVC-isolation in Redo-AF Ablation With Isolated PV

NCT07112716 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-08

No results posted yet for this study

Summary

Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed "pulmonary vein isolation"), which results in abolishment of arrhythmia recurrence in up to 85% of patients at short and mid-term follow-up. However, a subset of patients experience an atrial tachyarrhytmia recurrence and a second catheter ablation procedure has to be performed. If pulmary vein isolation is proven to be durable, other arrhythmogenic foci could be implicated in arrhythmia recurrence. Among extra-pulmonary vein foci, superior vena cava has been described as the most frequently involved in atrial fibrillation initiation. Therefore, its ablation could result in improved freedom from atrial fibrillation episodes during follow-up. In the present study, we sought to evaluate the safety and effectiveness of empirical superior vena cava isolation in terms of arrhythmia-free survival in patients with paroxysmal atrial fibrillation recurrence despite durable pulmonary vein isolation.

Conditions

  • Paroxysmal AF

Interventions

PROCEDURE

Empirical superior vena cava isolation

Empirical superior vena cava isolation with radiofrequency ablation

PROCEDURE

Ablation without empirical superior vena cava isolation

No ablation or ablation of other arrhythmic foci wuthout empirical superior vena cava isolation

Sponsors & Collaborators

  • Centro Medico Teknon

    lead OTHER

Principal Investigators

  • Antonio Berruezo, MD, PhD · Teknon Medical Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Spain

Study Locations

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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 NCT07112716 on ClinicalTrials.gov