Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter (LowVOLT-AF)

University of Luebeck

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Device: Volt™ Pulsed Field Ablation System

Study type: Interventional

Funder types: Other

Identifiers

NCT07587541

2025-544

Details and patient eligibility

About

The primary objective of this study is to determine whether low-voltage areas (LVA)-guided catheter ablation combined with superior vena cava (SVC) isolation and pulmonary vein isolation (PVI), performed using the balloon-in-basket Volt™ pulsed field ablation PFA system, is superior to PVI alone using same technology in reducing arrhythmia recurrence at 6 and 12 months in patients with persistent AF and detectable significant LVAs on three-dimensional electroanatomical mapping.

Moreover, the study will investigate, in a separate randomized cohort, the effect of adding SVC isolation to PVI using the balloon-in-basket Volt™ PFA system, compared with PVI alone, in patients with persistent AF without detectable significant LVAs during three-dimensional electroanatomical mapping.

Enrollment: 618 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Participants must meet all the following criteria:

1. Age ≥18 years
2. Persistent AF, defined as continuous AF lasting at least 7 days
3. Indication for catheter ablation according to the latest ESC guidelines
4. Written informed consent

Exclusion criteria

Participants will be excluded if any of the following criteria apply:

1. Inability or unwillingness to provide informed consent
2. Continuous AF duration duration of ≥2 years
3. Documented atrial tachycardia or atrial flutter
4. Previous left atrial catheter ablation or cardiac surgery
5. Planned cardiac surgery within the first 3 months after inclusion
6. History of heart transplantation, current listing for transplantation, or planned cardiac assist device implantation
7. Severe mitral or aortic valvular disease, according to the ESC guidelines
8. Platelet count <50,000 cells/mm³
9. Body mass index >45 kg/m² or <18 kg/m²
10. Untreated thyroid dysfunction (patients may be included once hypothyroidism or hyperthyroidism is adequately treated)
11. Absolute contraindication to oral anticoagulation
12. Any comorbidity that limits life expectancy to <1 year
13. Active systemic infection (enrolment permitted after successful treatment)
14. Women who are pregnant or breastfeeding
15. Women of childbearing potential not using highly effective contraception (PEARL Index <1%)
16. End-stage renal disease (GFR <15 ml/min/1.73 m2) or hepatic failure (Child Pugh C)
17. Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV
18. Participation in another randomized controlled trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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618 participants in 4 patient groups

LVA-guided catheter ablation combined with SVC isolation and PVI

Experimental group

Treatment:

Device: Volt™ Pulsed Field Ablation System

Device: Volt™ Pulsed Field Ablation System

LVA-guided catheter ablation combined with PVI alone

Active Comparator group

Treatment:

Device: Volt™ Pulsed Field Ablation System

Device: Volt™ Pulsed Field Ablation System

SVC isolation and PVI in patients without detectable significant LVA

Experimental group

Treatment:

Device: Volt™ Pulsed Field Ablation System

Device: Volt™ Pulsed Field Ablation System

PVI alone in patients without detectable significant LVA

Active Comparator group

Treatment:

Device: Volt™ Pulsed Field Ablation System

Device: Volt™ Pulsed Field Ablation System