NCT04702451

Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: Volta Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI). The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Dispersion ablation + PVI	Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
DEVICE	VX1	VX1-based dispersion mapping
PROCEDURE	PVI	Pulmonary vein antrum isolation

Timeline

• Start date: 2021-02-12
• Primary completion: 2023-12-27
• Completion: 2023-12-27
• First posted: 2021-01-08
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

26 sites across 5 countries: United States, Belgium, France, Germany, Netherlands

Regulatory

• FDA-regulated device study