SVC-isolation in Redo-AF Ablation With Isolated PV

NCT07112716 | Not Yet Recruiting

• 1 other identifier: SVC-RESCUE-AF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal AF

Keywords

Atrial fibrillation; Paroxysmal; Recurrence; Superior Vena Cava Isolation

Outcome Measures

Primary Outcomes (1)

• Arrhythmia-free survival

  Occurence of any sustained atrial arrhythmia (AF, atrial flutter or any atrial tachycardia) lasting ≥ 30 s, after a 2-month blanking period

  12 months follow-up

Secondary Outcomes (1)

• Procedure-related complications

  12 months follow-up

Study Arms (2)

SVC isolation group

ACTIVE COMPARATOR

Empirical superior vena cava isolation

Procedure: Empirical superior vena cava isolation

Control arm

SHAM COMPARATOR

No empirical superior vena cava isolation

Procedure: Ablation without empirical superior vena cava isolation

Interventions

Empirical superior vena cava isolation PROCEDURE

Empirical superior vena cava isolation with radiofrequency ablation

SVC isolation group

Ablation without empirical superior vena cava isolation PROCEDURE

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

Control arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Heart Institute, Teknon Medical Centre

Barcelona, Barcelona, 08034, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio Berruezo, MD, PhD

  Teknon Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Berruezo, MD, PhD

CONTACT

93 290 62 51; antonio.berruezo@quironsalud.es

Diego Penela, MD, PhD

CONTACT

diego.penelamaceda@humanitas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

ES (1)