Actively Recruiting
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.
Led by Heart Rhythm Clinical and Research Solutions, LLC · Updated on 2025-10-31
250
Participants Needed
21
Research Sites
209 weeks
Total Duration
On this page
Sponsors
H
Heart Rhythm Clinical and Research Solutions, LLC
Lead Sponsor
B
Biosense Webster, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic drug refractory paroxysmal atrial fibrillation (episodes end spontaneously within 7 days) and considered candidates for ablation by the investigator
- Age 18 years or older
- Able and willing to participate in baseline and follow-up evaluations for the entire sub-study duration
- Willing and able to provide informed consent for this sub-study
You will not qualify if you...
- Previous catheter ablation for atrial fibrillation (including PVI, roof line, or posterior wall ablation)
- Currently enrolled in an investigational drug or device clinical trial or any trial that dictates treatment
- Persistent or long-standing persistent atrial fibrillation
- Any known contraindication to an ablation procedure as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Arrhythmia Institute at Grandview
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Mobile Cardiology Associates
Mobile, Alabama, United States, 36608
Actively Recruiting
3
Community Memorial Health System
Ventura, California, United States, 93003
Actively Recruiting
4
Medical City - HCA
Aurora, Colorado, United States, 80012
Actively Recruiting
5
Naples Community Hospital
Naples, Florida, United States, 34102
Withdrawn
6
Sarasota Memorial Health
Sarasota, Florida, United States, 34239
Actively Recruiting
7
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Actively Recruiting
8
Norton Heart and Vascular Institute
Louisville, Kentucky, United States, 40205
Actively Recruiting
9
The Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
10
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912
Actively Recruiting
11
Trinity Health-Michigan Heart
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
12
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
13
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
14
University of Pennsylvania (UPENN)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Allegheny Health
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
16
Centra Health, Inc.dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Actively Recruiting
17
Bon Secours Medical Group - Richmond Specialty Care
Richmond, Virginia, United States, 23226
Actively Recruiting
18
Valley Health System
Winchester, Virginia, United States, 22601
Actively Recruiting
19
Multicare Health Systems-Pulse Heart
Puyallup, Washington, United States, 98372
Actively Recruiting
20
Franciscan Heart and Vascular Associates
Tacoma, Washington, United States, 98401
Actively Recruiting
21
Mercy Health
Janesville, Wisconsin, United States, 53548
Actively Recruiting
Research Team
J
Jennifer Moss
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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