Clinical Trial

The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.

Study acronym: QDOT PAS
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 31, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-03-19; most recent amendment 2025-10-29.
Trial Details
NCT Number NCT06324201
Lead Sponsor Heart Rhythm Clinical and Research Solutions, LLC
Collaborators: Biosense Webster, Inc.
Conditions Paroxysmal Atrial Fibrillation
Enrollment 250 participants
Start Date 2024-02-27
Primary Completion 2026-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2025-10-31