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NCT Number: NCT06324201

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, 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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Institute at Grandview, Birmingham, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
  • 18 years of age or older
  • Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
  • Willing and able to provide informed consent for this sub-study

Exclusion criteria

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

Treatment and study plan

Ablation procedure

Device

Ablation Procedure for paroxysmal atrial fibrillation

Primary outcomes

  1. Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module

    Time frame: Day 0-7 post ablation

    Adverse events from post-procedure through 7-day post ablation visit.

  2. Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.

    Time frame: 12 months

    Freedom from atrial arrhythmia recurrence at 12 months post procedure.

  3. Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.

    Time frame: 24 months

    Freedom from atrial arrhythmia recurrence at 24 months post procedure.

  4. Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.

    Time frame: 36 months

    Freedom from atrial arrhythmia recurrence at 36 months post procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Moss

CONTACT

[email protected]

615-448-5770

Sponsors and collaborators

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

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

Acronym: QDOT PAS

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 21, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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