Skip to content

SVC-isolation in Redo-AF Ablation With Isolated PV

Superior Vena Cava Isolation With Radiofrequency Ablation in Patients With Recurrent Paroxysmal Atrial Fibrillation and Durably Isolated Pulmonary Veins: A Multicenter Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07112716
Acronym
SVC-RESCUE-AF
Enrollment
100
Registered
2025-08-08
Start date
2025-09-01
Completion date
2027-07-01
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal AF

Keywords

Atrial fibrillation, Paroxysmal, Recurrence, Superior Vena Cava Isolation

Brief 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.

Detailed description

Atrial fibrillation (AF) is the most frequent arrhythmia in the general population (1), with an expected doubling in prevalence within 2060 (2). Since the late 1990s (3), pulmonary vein isolation (PVI) has become a cornerstone in drug refractory AF treatment, and more recently has emerged a first line therapy in paroxysmal AF patients (4) due to its proven superiority to antiarrhythmic drugs in achieving arrhythmia-free survival (5). PVI is a safe and effective procedure in the vast majority of patients with paroxysmal AF, with high AF-free survival at mid- and long-term follow-up. In case of AF recurrence, repeat ablation of pulmonary vein reconnections demonstrated superior outcomes compared to the use of anti-arrhythmic drugs in both paroxysmal and persistent AF (6). Nevertheless, a subset of patients with AF recurrence results to be PVI non-responder, with arrhythmia recurrence despite durable ablation results (7). How to manage these patients is still a matter of debate, with different additional lesion sets proposed so far (8). Non-PVI triggers have been implicated in AF initiation, with superior vena cava (SVC) being the most common of them (9,10). Empirical SVC isolation has been attempted in some observational as well as randomized study (11-14), but definitive conclusion could not be drawn due to lack of statistical power as well as variable eligibility criteria (first vs repeat procedure, paroxysmal vs persistent AF) and ablation sets (15). In the present study, we sought to evaluate the safety and effectiveness of empirical SVC isolation in terms of arrhythmia-free survival in patients with paroxysmal AF recurrence despite durable PVI.

Interventions

PROCEDUREEmpirical superior vena cava isolation

Empirical superior vena cava isolation with radiofrequency ablation

PROCEDUREAblation without empirical superior vena cava isolation

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

Sponsors

Centro Medico Teknon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \> 18 years. 2. Confirmed diagnosis of recurrent paroxysmal AF 3. Previous transcatheter PVI-only procedure for AF. 4. Evidence of persistently isolated pulmonary veins at repeat procedure. 5. Signed informed consent.

Exclusion criteria

* Age \< 18 years. * Pregnancy. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study. * Lesions other than PVI performed during first procedure * Persistent AF at recurrence. * Evidence of pulmonary vein reconnection at repeat procedure. * Any additional lesion performed beyond SVC isolation during repeat procedure (in the empirical SVC isolation group only).

Design outcomes

Primary

MeasureTime frameDescription
Arrhythmia-free survival12 months follow-upOccurence of any sustained atrial arrhythmia (AF, atrial flutter or any atrial tachycardia) lasting ≥ 30 s, after a 2-month blanking period

Secondary

MeasureTime frameDescription
Procedure-related complications12 months follow-upAny procedure complication

Countries

Spain

Contacts

Primary ContactAntonio Berruezo, MD, PhD
antonio.berruezo@quironsalud.es93 290 62 51
Backup ContactDiego Penela, MD, PhD
diego.penelamaceda@humanitas.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026