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. (QDOT PAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Ablation Procedure

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Carla Perna; Phone Number: 205-223-0960; Email: cperna@hrcrs.com

Study Locations

• United States
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Recruiting
      • Centra Health, Inc.dba Stroobants Cardiovascular Center
      • Contact: Cindy Baumann
      • Principal Investigator: Mathhew Sackett
  • Wisconsin
    • Janesville, Wisconsin, United States, 53548
      • Recruiting
      • Mercy Health
      • Contact: Kaitlyn Phetteplace
      • Principal Investigator: Imdad Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module	Adverse events from post-procedure through 7-day post ablation visit.	Day 0-7 post ablation
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.	12 months
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.	24 months
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.	36 months

Collaborators and Investigators

• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
• Collaborators: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: QDOT PAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No