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NCT06324201Recruiting

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.

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

Source: ClinicalTrials.gov · Last updated 31 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
21 Feb 2024
Start date
27 Feb 2024
Primary completion date
31 Mar 2026
Lead sponsor
Heart Rhythm Clinical and Research Solutions, LLC
NCT number
NCT06324201

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 27 Feb 2024 to the primary completion date, 31 Mar 2026
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan

Other

  • Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
  • Persistent or long-standing persistent AF
  • In the opinion of the investigator, any known contraindication to an ablation procedure

Who the study is looking for

  • Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
  • 18 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Piedmont Healthcare
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Medical City - HCA
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Arrhythmia Institute at Grandview
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
The Brigham and Womens Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesNot yet recruiting
University of Cincinnati
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CincinnatiUnited StatesRecruiting
The Christ Hospital
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
Mercy Health
Coordinator of this site? Confirm its status
JanesvilleUnited StatesRecruiting
Sparrow Clinical Research Institute
Coordinator of this site? Confirm its status
LansingUnited StatesRecruiting
Norton Heart and Vascular Institute
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Centra Health, Inc. dba Stroobants Cardiovascular Center
Coordinator of this site? Confirm its status
LynchburgUnited StatesRecruiting
Mobile Cardiology Associates
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MobileUnited StatesRecruiting
Naples Community Hospital
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NaplesUnited StatesWithdrawn
University of Pennsylvania (UPENN)
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Allegheny Health
Coordinator of this site? Confirm its status
PittsburghUnited StatesRecruiting
Multicare Health Systems-Pulse Heart
Coordinator of this site? Confirm its status
PuyallupUnited StatesRecruiting
Bon Secours Medical Group - Richmond Specialty Care
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
Sarasota Memorial Health
Coordinator of this site? Confirm its status
SarasotaUnited StatesRecruiting
Franciscan Heart and Vascular Associates
Coordinator of this site? Confirm its status
TacomaUnited StatesRecruiting
Community Memorial Health System
Coordinator of this site? Confirm its status
VenturaUnited StatesRecruiting
Valley Health System
Coordinator of this site? Confirm its status
WinchesterUnited StatesRecruiting
Trinity Health Michigan Heart
Coordinator of this site? Confirm its status
YpsilantiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.