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.
QDOT PAS
1 other identifier
observational
250
1 country
21
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, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedStudy Start
First participant enrolled
February 27, 2024
CompletedFirst Posted
Study publicly available on registry
March 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedOctober 31, 2025
October 1, 2025
2 years
February 21, 2024
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module
Adverse events from post-procedure through 7-day post ablation visit.
Day 0-7 post ablation
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.
Freedom from atrial arrhythmia recurrence at 12 months post procedure.
12 months
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.
Freedom from atrial arrhythmia recurrence at 24 months post procedure.
24 months
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.
Freedom from atrial arrhythmia recurrence at 36 months post procedure.
36 months
Interventions
Ablation Procedure for paroxysmal atrial fibrillation
Eligibility Criteria
Study population will consist of patients in the REAL AF registry who have symptomatic PAF and will have, or have undergone, ablation procedures using the QDOT MICRO™ System with VISITAG SURPOINT™ Module
You may qualify if:
- Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
- years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
- Willing and able to provide informed consent for this sub-study
You may not qualify if:
- Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- Persistent or long-standing persistent AF
- In the opinion of the investigator, any known contraindication to an ablation procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35209, United States
Mobile Cardiology Associates
Mobile, Alabama, 36608, United States
Community Memorial Health System
Ventura, California, 93003, United States
Medical City - HCA
Aurora, Colorado, 80012, United States
Naples Community Hospital
Naples, Florida, 34102, United States
Sarasota Memorial Health
Sarasota, Florida, 34239, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205, United States
The Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Trinity Health-Michigan Heart
Ypsilanti, Michigan, 48197, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati
Cincinnati, Ohio, 45221, United States
University of Pennsylvania (UPENN)
Philadelphia, Pennsylvania, 19104, United States
Allegheny Health
Pittsburgh, Pennsylvania, 15212, United States
Centra Health, Inc.dba Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Bon Secours Medical Group - Richmond Specialty Care
Richmond, Virginia, 23226, United States
Valley Health System
Winchester, Virginia, 22601, United States
Multicare Health Systems-Pulse Heart
Puyallup, Washington, 98372, United States
Franciscan Heart and Vascular Associates
Tacoma, Washington, 98401, United States
Mercy Health
Janesville, Wisconsin, 53548, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Sanchez, MD
J & J Corporation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2024
First Posted
March 21, 2024
Study Start
February 27, 2024
Primary Completion
March 1, 2026
Study Completion (Estimated)
March 1, 2028
Last Updated
October 31, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share