RecruitingNCT06324201

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.

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

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Enrollment

250 participants

Start Date

Feb 27, 2024

Study Type

OBSERVATIONAL

Conditions

Paroxysmal Atrial Fibrillation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the long-term safety and effectiveness of the QDOT MICRO ablation system used during a heart procedure called catheter ablation for atrial fibrillation. Atrial fibrillation (AFib) is an irregular heart rhythm, and ablation involves using heat to destroy the tiny areas of the heart causing the abnormal rhythm. **You may be eligible if:** - You have been diagnosed with paroxysmal atrial fibrillation (episodes that start and stop on their own within 7 days) that causes symptoms and has not responded to medication - You are 18 years or older - You and your doctor have decided that catheter ablation is the right treatment for you - You are willing to attend follow-up appointments for the full study duration **You may NOT be eligible if:** - You have had a prior catheter ablation procedure for atrial fibrillation - You are enrolled in another investigational drug or device trial - You have persistent or long-standing persistent AFib (episodes lasting longer than 7 days) - Your doctor determines you have a contraindication to ablation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAblation Procedure

Ablation Procedure for paroxysmal atrial fibrillation

Locations(21)

Arrhythmia Institute at Grandview

Birmingham, Alabama, United States

Mobile Cardiology Associates

Mobile, Alabama, United States

Community Memorial Health System

Ventura, California, United States

Medical City - HCA

Aurora, Colorado, United States

Naples Community Hospital

Naples, Florida, United States

Sarasota Memorial Health

Sarasota, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Norton Heart and Vascular Institute

Louisville, Kentucky, United States

The Brigham and Womens Hospital

Boston, Massachusetts, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Trinity Health-Michigan Heart

Ypsilanti, Michigan, United States

The Christ Hospital

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

University of Pennsylvania (UPENN)

Philadelphia, Pennsylvania, United States

Allegheny Health

Pittsburgh, Pennsylvania, United States

Centra Health, Inc.dba Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Bon Secours Medical Group - Richmond Specialty Care

Richmond, Virginia, United States

Valley Health System

Winchester, Virginia, United States

Multicare Health Systems-Pulse Heart

Puyallup, Washington, United States

Franciscan Heart and Vascular Associates

Tacoma, Washington, United States

Mercy Health

Janesville, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06324201

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