NCT04904354

AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation

AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Acutus Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study.

Detailed description

The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing System in the ablation treatment of symptomatic, drug-refractory atrial fibrillation in two subject cohorts: paroxysmal atrial fibrillation, and persistent atrial fibrillation. Data will be used to support pre-market approval applications (PMAs).

Conditions

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	AcQBlate® Force Sensing Ablation System	Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein. Additional left and right atrial targets may be ablated as clinically indicated.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-01
• Completion: 2025-12-01
• First posted: 2021-05-27
• Last updated: 2023-11-13

Regulatory

• FDA-regulated device study