Recruiting

QDOT MICRO & VISITAG SURPOINTThe 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.

Sponsor:

Heart Rhythm Clinical and Research Solutions, LLC

Code:

NCT06324201

Conditions

Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ablation Procedure

Study Details

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

Conditions

Paroxysmal Atrial Fibrillation

Study ID

NCT06324201

Start date

Feb 27, 2024

Status verified date

Oct, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Interventions

Ablation Procedure

Ablation Procedure for paroxysmal atrial fibrillation

Primary outcome measure

Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module [ Time Frame: 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 ]
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months. [ Time Frame: 24 months ]
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months. [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Jennifer Moss

615-448-5770 jmoss@hrcrs.com

Locations

Arrhythmia Institute at Grandview

Recruiting

Birmingham, Alabama, United States, 35209

Principal Investigator:

Anil Rajendra, MD

Mobile Cardiology Associates

Recruiting

Mobile, Alabama, United States, 36608

Principal Investigator:

Matthew E Quin, MD

Community Memorial Health System

Recruiting

Ventura, California, United States, 93003

Principal Investigator:

Jonathan Dukes, MD

Medical City - HCA

Recruiting

Aurora, Colorado, United States, 80012

Principal Investigator:

Christopher Porterfield, MD

Sarasota Memorial Health

Recruiting

Sarasota, Florida, United States, 34239

Principal Investigator:

Antonio Moretta, MD

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator:

Sandeep Goyal, MD

Norton Heart and Vascular Institute

Recruiting

Louisville, Kentucky, United States, 40205

Principal Investigator:

Kent Morris, MD

Sparrow Clinical Research Institute

Recruiting

Lansing, Michigan, United States, 48912

Principal Investigator:

Ali Sheikh, DO

Trinity Health-Michigan Heart

Recruiting

Ypsilanti, Michigan, United States, 48197

Principal Investigator:

Mohammad-Ali Jazayeri, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Alexandru Costea, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45221

Principal Investigator:

Srinivas Rajsheker, MD

University of Pennsylvania (UPENN)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Benjamin D'Souza, MD

Allegheny Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Joshua Silverstein, MD

Centra Health, Inc.dba Stroobants Cardiovascular Center

Recruiting

Lynchburg, Virginia, United States, 24501

Principal Investigator:

Mathhew Sackett

Bon Secours Medical Group - Richmond Specialty Care

Recruiting

Richmond, Virginia, United States, 23226

Principal Investigator:

An Bui, MD

Valley Health System

Recruiting

Winchester, Virginia, United States, 22601

Principal Investigator:

Emmanuel Ekanem, MD

Multicare Health Systems-Pulse Heart

Recruiting

Puyallup, Washington, United States, 98372

Principal Investigator:

Tariq Salam, MD

Franciscan Heart and Vascular Associates

Recruiting

Tacoma, Washington, United States, 98401

Principal Investigator:

Nasir Shariff, MD

Mercy Health

Recruiting

Janesville, Wisconsin, United States, 53548

Principal Investigator:

Imdad Ahmed

More Information

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Heart Rhythm Clinical and Research Solutions, LLC on 2025-10-31.