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.

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06324201

Acronym

QDOT PAS

Enrollment

250

Registered

2024-03-21

Start date

2024-02-27

Completion date

2028-03-31

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Brief summary

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.

Detailed description

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

Interventions

DEVICEAblation Procedure

Ablation Procedure for paroxysmal atrial fibrillation

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module	Day 0-7 post ablation	Adverse events from post-procedure through 7-day post ablation visit.
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.	12 months	Freedom from atrial arrhythmia recurrence at 12 months post procedure.
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.	24 months	Freedom from atrial arrhythmia recurrence at 24 months post procedure.
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.	36 months	Freedom from atrial arrhythmia recurrence at 36 months post procedure.

Countries

United States

Contacts

Primary ContactJennifer Moss

jmoss@hrcrs.com615-448-5770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026