Clinical trial NCT06324201: 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.
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2024-03-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of patients in the REAL AF registry who have symptomatic PAF and undergo ablation procedures using the QDOT MICRO™ System with VISITAG SURPOINT™ Module

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module
timeFrame: Day 0-7 post ablation
measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.
timeFrame: 12 months
measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.
timeFrame: 24 months
measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lynchburg
country: United States
facility: Centra Health, Inc.dba Stroobants Cardiovascular Center
state: Virginia
city: Janesville
country: United States
facility: Mercy Health
state: Wisconsin
Study officials:
References: