Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324201
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-02-21
Brief Title:
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
Sponsor:
Heart Rhythm Clinical and Research Solutions LLC
Organization:
Heart Rhythm Clinical and Research Solutions LLC
Study Overview
Official Title:
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINTModule for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QDOT PAS
Brief 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 to this sub-study per inclusion and exclusion criteria
Detailed Description:
Enrolled QDOT PAS subjects are defined as consented patients with symptomatic paroxysmal atrial fibrillation PAF enrolled in the REAL AF registry These enrolled subjects will be treated with the commercially available QDOT MICRO system QDOT MICRO catheter and nGEN generator in conjunction with VISITAG SURPOINT Module Subjects are required to complete scheduled assessments within 12 months of the index procedure and additional two assessments at 24 and 36-months post procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None