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.

Last updated: October 29, 2025
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Chest Pain

Atrial Fibrillation

Treatment

Ablation Procedure

Clinical Study ID

NCT06324201
QDOT PAS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. 18 years of age or older

  3. Able and willing to participate in baseline and follow up evaluations for the fulllength of the sub-study

  4. Willing and able to provide informed consent for this sub-study

Exclusion

Exclusion Criteria:

  1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roofline, posterior wall ablation...)

  2. Enrolled in an investigational drug or device clinical trial, or any trial thatdictates the treatment plan

  3. Persistent or long-standing persistent AF

  4. In the opinion of the investigator, any known contraindication to an ablationprocedure

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Ablation Procedure
Phase:
Study Start date:
February 27, 2024
Estimated Completion Date:
March 31, 2028

Study 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. Retrospective consecutive patients from the REAL AF registry, who were ablated with the QDOT MICRO™ system, may be enrolled into the sub-study if the patient meets eligibility criteria and provides consent for additional follow-up of 24 and 36-months

Connect with a study center

  • Arrhythmia Institute at Grandview

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Mobile Cardiology Associates

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Arrhythmia Institute at Grandview

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Active - Recruiting

  • Mobile Cardiology Associates

    Mobile 4076598, Alabama 4829764 36608
    United States

    Active - Recruiting

  • Community Memorial Health System

    Ventura, California 93003
    United States

    Site Not Available

  • Community Memorial Health System

    Ventura 5405878, California 5332921 93003
    United States

    Active - Recruiting

  • Medical City - HCA

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Medical City - HCA

    Aurora 5412347, Colorado 5417618 80012
    United States

    Active - Recruiting

  • Naples Community Hospital

    Naples, Florida 34102
    United States

    Site Not Available

  • Sarasota Memorial Health

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Naples Community Hospital

    Naples 4165565, Florida 4155751 34102
    United States

    Site Not Available

  • Sarasota Memorial Health

    Sarasota 4172131, Florida 4155751 34239
    United States

    Active - Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Piedmont Healthcare

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Active - Recruiting

  • Norton Heart and Vascular Institute

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Norton Heart and Vascular Institute

    Louisville 4299276, Kentucky 6254925 40205
    United States

    Active - Recruiting

  • The Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • The Brigham and Womens Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Trinity Health-Michigan Heart

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing 4998830, Michigan 5001836 48912
    United States

    Active - Recruiting

  • Trinity Health-Michigan Heart

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45221
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati 4508722, Ohio 5165418 45221
    United States

    Active - Recruiting

  • University of Pennsylvania (UPENN)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allegheny Health

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • University of Pennsylvania (UPENN)

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Allegheny Health

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Active - Recruiting

  • Centra Health, Inc.dba Stroobants Cardiovascular Center

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Bon Secours Medical Group - Richmond Specialty Care

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Valley Health System

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Centra Health, Inc.dba Stroobants Cardiovascular Center

    Lynchburg 4771075, Virginia 6254928 24501
    United States

    Active - Recruiting

  • Bon Secours Medical Group - Richmond Specialty Care

    Richmond 4781708, Virginia 6254928 23226
    United States

    Active - Recruiting

  • Valley Health System

    Winchester 4794120, Virginia 6254928 22601
    United States

    Active - Recruiting

  • Multicare Health Systems-Pulse Heart

    Puyallup, Washington 98372
    United States

    Site Not Available

  • Franciscan Heart and Vascular Associates

    Tacoma, Washington 98401
    United States

    Site Not Available

  • Multicare Health Systems-Pulse Heart

    Puyallup 5807575, Washington 5815135 98372
    United States

    Active - Recruiting

  • Franciscan Heart and Vascular Associates

    Tacoma 5812944, Washington 5815135 98401
    United States

    Active - Recruiting

  • Mercy Health

    Janesville, Wisconsin 53548
    United States

    Site Not Available

  • Mercy Health

    Janesville 5257754, Wisconsin 5279468 53548
    United States

    Active - Recruiting

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