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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.

Studying long-term safety of QDOT MICRO for difficult-to-treat atrial fibrillation.

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

This study looks at the long-term safety and effectiveness of using the QDOT MICRO™ system with the VISITAG SURPOINT™ Module to treat a heart condition called paroxysmal atrial fibrillation (PAF). PAF is when the heart beats irregularly, and these episodes stop on their own within 7 days. The study includes patients who haven't been helped by medicine and are part of the REAL AF registry, a group of people with this condition. Participants will use the QDOT MICRO™ catheter and nGEN™ generator during their treatment. They need to complete assessments up to 36 months after their procedure.

Key Points:

  • Duration: Participants will be in the study for up to 36 months with several check-ups.
  • Eligibility: Must be 18+, experiencing PAF, and willing to provide consent.
  • Exclusions: Previous ablation or involvement in other trials that affect treatment disqualify participation.
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Study details
    Paroxysmal Atrial Fibrillation

NCT06324201

Heart Rhythm Clinical and Research Solutions, LLC

12 July 2025

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