Evaluating the QDOT MICRO System for treating drug-resistant paroxysmal atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arrhythmia Institute at Grandview
  Birmingham, Alabama, United States Recruiting
• Mobile Cardiology Associates
  Mobile, Alabama, United States Recruiting
• Community Memorial Health System
  Ventura, California, United States Recruiting
• Medical City - HCA
  Aurora, Colorado, United States Recruiting
• Sarasota Memorial Health
  Sarasota, Florida, United States Recruiting
• Piedmont Healthcare
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Jennifer Moss
• Email: jmoss@hrcrs.com
• Phone: 615-448-5770

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.