NCT03775512

Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation

Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation (PVI) in Subjects With PAF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.

Detailed description

Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal. the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and second arm will enroll 92 subjects.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	RF Ablation with QDOT Micro	Subjects will be ablated using QDOT Micro catheter

Timeline

• Start date: 2019-01-30
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2018-12-14
• Last updated: 2023-03-16
• Results posted: 2023-03-16

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study