QDOT MICRO System for Atrial Fibrillation
(QDOT PAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the long-term safety and effectiveness of a new system called QDOT MICRO, combined with another tool, to treat individuals with paroxysmal atrial fibrillation (PAF). It targets those who continue to experience symptoms despite medication and may consider ablation to manage their condition. The trial suits individuals who have not undergone ablation before and are prepared to participate for the study's entire duration. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.
What is the safety track record for the QDOT MICRO System for Atrial Fibrillation?
In a previous study, the QDOT MICRO System demonstrated promising safety results for treating atrial fibrillation (AFib). This system delivers energy to the heart to correct irregular heartbeats. Research has shown that patients generally tolerate the system well. Side effects were usually mild, including temporary discomfort at the procedure site. Another study found that most patients did not experience serious complications within a year after treatment. The FDA has approved the QDOT MICRO System for treating AFib, indicating it meets safety standards for this condition.12345
Why are researchers excited about this trial?
The QDOT MICRO System, when used with the VISITAG SURPOINT Module, is unique because it aims to offer a more precise and efficient approach to treating symptomatic drug-refractory paroxysmal atrial fibrillation (AFib). Unlike traditional catheter ablation techniques, which can be time-consuming and require multiple sessions, this system uses advanced technology to enhance the precision and speed of the procedure. Researchers are excited about this treatment because it has the potential to improve patient outcomes by reducing the overall procedure time and increasing the accuracy of lesion creation, which could lead to better long-term success rates in managing AFib.
What evidence suggests that the QDOT MICRO System is effective for atrial fibrillation?
Research has shown that the QDOT MICRO System effectively treats atrial fibrillation (AFib). In one study, 99% of patients achieved better control of their AFib, and 93.1% experienced symptom relief within a year. Another study found that 82.1% of patients did not experience a return of AFib after 12 months. These results suggest that the QDOT MICRO System significantly helps manage AFib symptoms and reduces episodes over time.14678
Who Is on the Research Team?
Brian Sanchez, MD
Principal Investigator
J & J Corporation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with the QDOT MICRO system in conjunction with VISITAG SURPOINT Module
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Heart Rhythm Clinical and Research Solutions, LLC
Lead Sponsor
Biosense Webster, Inc.
Industry Sponsor
Dr. Nick West
Biosense Webster, Inc.
Chief Medical Officer
MD from Harvard Medical School
Jasmina Brooks
Biosense Webster, Inc.
Chief Executive Officer since 2023
Bachelor of Science in Biomedical Engineering from Louisiana Tech University
Citations
1.
jnjmedtech.com
jnjmedtech.com/en-US/news-events/new-biosense-webster-qdot-micro-catheter-data-demonstrate-very-high-power-shortNew Biosense Webster QDOT MICRO™ Catheter Data ...
The study found a 99% and 93.1% improvement in control of AFib and relief of AFib symptoms, respectively, at 12-month follow-up compared to baseline.
Very High-Power Short-Duration, Temperature-Controlled ...
The Kaplan-Meier estimated 12-month rate for primary effectiveness success was 76.7%; freedom from atrial tachyarrhythmia recurrence was 82.1%; ...
Temperature-Controlled Catheter Ablation for Paroxysmal ...
The QDOT-MICRO feasibility study evaluated the workflow, performance, and safety of temperature-controlled catheter ablation in patients with symptomatic ...
Real world data on the use of the QDOT Micro catheter for ...
We aimed to report real world data on acute efficacy and safety from a large cohort of atrial fibrillation (AF) patients ablated in the AIR HPSD ...
summary of safety and effectiveness data (ssed)
The QDOT MICRO™ System is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction.
6.
jnjmedtech.com
jnjmedtech.com/en-US/news-events/new-data-published-biosense-webster-qdot-micro-catheter-latest-advancement-focal-rfNew Data Published on Biosense Webster QDOT MICRO ...
The study evaluated the safety and 12-month effectiveness of the QDOT MICRO™ Catheter in paroxysmal atrial fibrillation (AFib) ablation using ...
Study Details | NCT06324201 | The Long-term Safety and ...
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic ...
Safety and effectiveness of very-high-power, short-duration ...
A very-high-power, short-duration (vHPSD) catheter, QDot Micro™ (Biosense Webster) was designed to improve the effectiveness of AF ablation within a shorter ...
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