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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.

ConditionParoxysmal Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Rhythm Clinical and Research Solutions, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Study population will consist of patients in the REAL AF registry who have symptomatic PAF and will have, or have undergone, ablation procedures using the QDOT MICRO™ System with VISITAG SURPOINT™ Module

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Ablation Procedure

    Device

    Ablation Procedure for paroxysmal atrial fibrillation

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

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

Time frame
Day 0-7 post ablation
2

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

Freedom from atrial arrhythmia recurrence at 12 months post procedure.

Time frame
12 months
3

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

Freedom from atrial arrhythmia recurrence at 24 months post procedure.

Time frame
24 months
4

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

Freedom from atrial arrhythmia recurrence at 36 months post procedure.

Time frame
36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Rhythm Clinical and Research Solutions, LLC

Lead sponsor

Biosense Webster, Inc.

Collaborator

Source ClinicalTrials.gov
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