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Paroxysmal Atrial FibrillationQDOT PASNCT06324201

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.

An observational study of Paroxysmal Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC at 21 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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, prospectively or retrospectively, to this sub-study per inclusion… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
Ablation Procedure
Type of treatment
Medical device
How many people
250 participants
Where
21 sitesUnited States
Study dates
27 Feb 2024to Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
  • 18 years of age or older
  • Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
  • Willing and able to provide informed consent for this sub-study

Who cannot join

  • Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
  • Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
  • Persistent or long-standing persistent AF
  • In the opinion of the investigator, any known contraindication to an ablation procedure

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Moss contact

615-448-5770

jmoss@hrcrs.com

21 sites in 1 country

United States21 sites, 20 recruiting

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

    Sandeep Goyal, MD

    Recruiting

  • Medical City - HCA

    Aurora, Colorado, 80012

    Christopher Porterfield, MD

    Recruiting

  • Arrhythmia Institute at Grandview

    Birmingham, Alabama, 35209

    Anil Rajendra, MD

    Recruiting

  • The Brigham and Womens Hospital

    Boston, Massachusetts, 02115

    Jorge Romero, MD

    Not yet recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Alexandru Costea, MD

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45221

    Srinivas Rajsheker, MD

    Recruiting

  • Mercy Health

    Janesville, Wisconsin, 53548

    Kaitlyn Phetteplace

    Imdad Ahmed

    Recruiting

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

    Ali Sheikh, DO

    Recruiting

  • Norton Heart and Vascular Institute

    Louisville, Kentucky, 40205

    Kent Morris, MD

    Recruiting

  • Centra Health, Inc.dba Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501

    Cindy Baumann

    Mathhew Sackett

    Recruiting

  • Mobile Cardiology Associates

    Mobile, Alabama, 36608

    Matthew E Quin, MD

    Recruiting

  • Naples Community Hospital

    Naples, Florida, 34102

    Withdrawn

  • University of Pennsylvania (UPENN)

    Philadelphia, Pennsylvania, 19104

    Benjamin D'Souza, MD

    Recruiting

  • Allegheny Health

    Pittsburgh, Pennsylvania, 15212

    Joshua Silverstein, MD

    Recruiting

  • Multicare Health Systems-Pulse Heart

    Puyallup, Washington, 98372

    Tariq Salam, MD

    Recruiting

  • Bon Secours Medical Group - Richmond Specialty Care

    Richmond, Virginia, 23226

    An Bui, MD

    Recruiting

  • Sarasota Memorial Health

    Sarasota, Florida, 34239

    Antonio Moretta, MD

    Recruiting

  • Franciscan Heart and Vascular Associates

    Tacoma, Washington, 98401

    Nasir Shariff, MD

    Recruiting

  • Community Memorial Health System

    Ventura, California, 93003

    Jonathan Dukes, MD

    Recruiting

  • Valley Health System

    Winchester, Virginia, 22601

    Emmanuel Ekanem, MD

    Recruiting

  • Trinity Health-Michigan Heart

    Ypsilanti, Michigan, 48197

    Mohammad-Ali Jazayeri, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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

Being tested
Ablation Procedure
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ablation ProcedureDevice

    Ablation Procedure for paroxysmal atrial fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module

    Adverse events from post-procedure through 7-day post ablation visit.

    Measured: Day 0-7 post ablation

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 24 months

  4. 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.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start27 Feb 2024
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06324201
Sponsor's protocol ID
QDOT PAS
Acronym
QDOT PAS
Status last verified
Oct 2025
First submitted
21 Feb 2024
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Paroxysmal Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Moss (615-448-5770, jmoss@hrcrs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module (time frame: Day 0-7 post ablation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06324201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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