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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ablation Procedure.
- Who it may be relevant to
- Registry conditions: Paroxysmal Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Device Ablation Procedure
Ablation Procedure for paroxysmal atrial fibrillation
Primary outcome measures
- Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module [Time frame: Day 0-7 post ablation]
- Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months. [Time frame: 12 months]
- Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months. [Time frame: 24 months]
- Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months. [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 21 centers
- Arrhythmia Institute at Grandview — Birmingham
- Mobile Cardiology Associates — Mobile
- Community Memorial Health System — Ventura
- Medical City - HCA — Aurora
- Naples Community Hospital — Naples
- Sarasota Memorial Health — Sarasota
- Piedmont Healthcare — Atlanta
- Norton Heart and Vascular Institute — Louisville
- … and 13 more centers
Identifiers
NCT: NCT06324201 · QDOT PAS