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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.

Study on safety and effectiveness of new system for atrial fibrillation.

Recruiting
18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study looks at how safe and effective a treatment is for paroxysmal atrial fibrillation (PAF), a condition where the heart beats irregularly for short periods. The study uses a special system called QDOT MICRO™ with a VISITAG SURPOINT™ Module to help with the treatment. This study is observational, meaning doctors will watch and record the effects instead of giving a new treatment.

Patients who join will have their heart condition observed for up to 36 months, with check-ups scheduled at 12, 24, and 36 months after the initial procedure. Eligibility includes being 18 or older and having PAF that doesn’t get better with drugs.

  • Study visits: 12, 24, and 36 months post-procedure.
  • Eligibility: Adults (18+) with drug-resistant PAF willing to participate.
  • Exclusions: Prior ablation, certain clinical trials, persistent AF.

Note: Participants must give consent and be prepared for follow-up visits. This study helps understand long-term treatment effects.

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Study details
    Paroxysmal Atrial Fibrillation

NCT06324201

Heart Rhythm Clinical and Research Solutions, LLC

22 August 2026

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