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)

October 29, 2025 updated by: Heart Rhythm Clinical and Research Solutions, LLC

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, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Arrhythmia Institute at Grandview
        • Principal Investigator:
          • Anil Rajendra, MD
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Mobile Cardiology Associates
        • Principal Investigator:
          • Matthew E Quin, MD
    • California
      • Ventura, California, United States, 93003
        • Recruiting
        • Community Memorial Health System
        • Principal Investigator:
          • Jonathan Dukes, MD
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Medical City - HCA
        • Principal Investigator:
          • Christopher Porterfield, MD
    • Florida
      • Naples, Florida, United States, 34102
        • Withdrawn
        • Naples Community Hospital
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Health
        • Principal Investigator:
          • Antonio Moretta, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont HealthCare
        • Principal Investigator:
          • Sandeep Goyal, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Norton Heart and Vascular Institute
        • Principal Investigator:
          • Kent Morris, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • The Brigham and Womens Hospital
        • Principal Investigator:
          • Jorge Romero, MD
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Clinical Research Institute
        • Principal Investigator:
          • Ali Sheikh, DO
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health-Michigan Heart
        • Principal Investigator:
          • Mohammad-Ali Jazayeri, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • Alexandru Costea, MD
      • Cincinnati, Ohio, United States, 45221
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Srinivas Rajsheker, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania (UPENN)
        • Principal Investigator:
          • Benjamin D'Souza, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health
        • Principal Investigator:
          • Joshua Silverstein, MD
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Centra Health, Inc.dba Stroobants Cardiovascular Center
        • Contact:
          • Cindy Baumann
        • Principal Investigator:
          • Mathhew Sackett
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours Medical Group - Richmond Specialty Care
        • Principal Investigator:
          • An Bui, MD
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Valley Health System
        • Principal Investigator:
          • Emmanuel Ekanem, MD
    • Washington
      • Puyallup, Washington, United States, 98372
        • Recruiting
        • Multicare Health Systems-Pulse Heart
        • Principal Investigator:
          • Tariq Salam, MD
      • Tacoma, Washington, United States, 98401
        • Recruiting
        • Franciscan Heart and Vascular Associates
        • Principal Investigator:
          • Nasir Shariff, MD
    • Wisconsin
      • Janesville, Wisconsin, United States, 53548
        • Recruiting
        • Mercy Health
        • Contact:
          • Kaitlyn Phetteplace
        • Principal Investigator:
          • Imdad Ahmed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 will have, or have undergone, 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Day 0-7 post ablation
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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 36 months
Freedom from atrial arrhythmia recurrence at 36 months post procedure.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Collaborators

Biosense Webster, Inc.

Investigators

  • Study Director: Brian Sanchez, MD, J & J Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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