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

LowVOLT-AF Study: Low-VOLTage Areas-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Device: Volt™ Pulsed Field Ablation System; Device: Volt™ Pulsed Field Ablation System

• Study Type: Interventional
• Enrollment (Estimated): 618
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roland R Tilz; Phone Number: +49 451 500-44511; Email: roland.tilz@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LVA-guided catheter ablation combined with SVC isolation and PVI	Device: Volt™ Pulsed Field Ablation System; SVC isolation; Device: Volt™ Pulsed Field Ablation System; PVI alone
Active Comparator: LVA-guided catheter ablation combined with PVI alone	Device: Volt™ Pulsed Field Ablation System; SVC isolation; Device: Volt™ Pulsed Field Ablation System; PVI alone
Experimental: SVC isolation and PVI in patients without detectable significant LVA	Device: Volt™ Pulsed Field Ablation System; SVC isolation; Device: Volt™ Pulsed Field Ablation System; PVI alone
Active Comparator: PVI alone in patients without detectable significant LVA	Device: Volt™ Pulsed Field Ablation System; SVC isolation; Device: Volt™ Pulsed Field Ablation System; PVI alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence of atrial arrhythmias defined as atrial fibrillation, atrial flutter or atrial tachycardia lasting ≥30 seconds occurring after a 2-month post-procedural blanking period.	within 6 months following catheter ablation.

Collaborators and Investigators

• Sponsor: University of Luebeck

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 2025-544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No