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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heart Rhythm Clinical and Research Solutions, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biosense Webster, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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