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.

Recruiting

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT06324201
• Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

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 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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study Start: 2024-02-27
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2026-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (2)

Centra Health, Inc.dba Stroobants Cardiovascular Center; 🇺🇸 Lynchburg, Virginia, United States

Mercy Health; 🇺🇸 Janesville, Wisconsin, United States