Home › Trials › NCT06324201

Evaluating the QDOT MICRO System for treating drug-resistant 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

Observational Heart Rhythm Clinical and Research Solutions, LLC · NCT06324201

This study is testing if a new system for heart ablation can safely and effectively help people with tough-to-treat paroxysmal atrial fibrillation feel better over the long term.

Quick facts

Study typeObservational
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorHeart Rhythm Clinical and Research Solutions, LLC Academic / other
Locations21 sites (Birmingham, Alabama and 20 other locations)
Trial IDNCT06324201 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term safety and effectiveness of the QDOT MICRO system combined with the VISITAG SURPOINT module in patients with symptomatic drug-refractory paroxysmal atrial fibrillation. Participants will be selected from the REAL AF registry and will undergo an ablation procedure using the QDOT MICRO system. They will be monitored through scheduled assessments at 12, 24, and 36 months post-procedure to evaluate outcomes. The study is non-randomized and multi-center, focusing on real-world effectiveness in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic drug-refractory paroxysmal atrial fibrillation who are suitable for ablation.

Not a fit: Patients who have previously undergone catheter ablation for atrial fibrillation or have persistent forms of AF may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from drug-refractory paroxysmal atrial fibrillation.

How similar studies have performed: Other studies have shown promising results with similar ablation techniques, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) 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 full length of the sub-study
4. Willing and able to provide informed consent for this sub-study

Exclusion Criteria:

1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
2. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
3. Persistent or long-standing persistent AF
4. In the opinion of the investigator, any known contraindication to an ablation procedure

Where this trial is running

Birmingham, Alabama and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Paroxysmal Atrial Fibrillation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.