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.
NCT06324201 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2025-10-31
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.
Conditions
- Paroxysmal Atrial Fibrillation
Interventions
- DEVICE
-
Ablation Procedure
Ablation Procedure for paroxysmal atrial fibrillation
Sponsors & Collaborators
-
Biosense Webster, Inc.
collaborator INDUSTRY -
Heart Rhythm Clinical and Research Solutions, LLC
lead OTHER
Principal Investigators
-
Brian Sanchez, MD · J & J Corporation
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-27
- Primary Completion
- 2026-03-31
- Completion
- 2028-03-31
Countries
- United States
Study Locations
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