What this study is
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.
What's being tested
- Ablation Procedure
Intervention · DEVICE
Ablation Procedure for paroxysmal atrial fibrillation
Study details
- 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
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Conditions
- Paroxysmal Atrial Fibrillation
- Enrolling
- 250 people
- Starts
- 2024-02-27
- Est. completion
- 2028-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (21)
20 openArrhythmia Institute at Grandview
Birmingham, Alabama, United States
- Anil Rajendra, MD · Principal investigator
RecruitingMobile Cardiology Associates
Mobile, Alabama, United States
- Matthew E Quin, MD · Principal investigator
RecruitingCommunity Memorial Health System
Ventura, California, United States
- Jonathan Dukes, MD · Principal investigator
RecruitingMedical City - HCA
Aurora, Colorado, United States
- Christopher Porterfield, MD · Principal investigator
RecruitingSarasota Memorial Health
Sarasota, Florida, United States
- Antonio Moretta, MD · Principal investigator
RecruitingPiedmont Healthcare
Atlanta, Georgia, United States
- Sandeep Goyal, MD · Principal investigator
RecruitingNorton Heart and Vascular Institute
Louisville, Kentucky, United States
- Kent Morris, MD · Principal investigator
RecruitingThe Brigham and Womens Hospital
Boston, Massachusetts, United States
- Jorge Romero, MD · Principal investigator
Not yet recruitingSparrow Clinical Research Institute
Lansing, Michigan, United States
- Ali Sheikh, DO · Principal investigator
RecruitingTrinity Health-Michigan Heart
Ypsilanti, Michigan, United States
- Mohammad-Ali Jazayeri, MD · Principal investigator
RecruitingThe Christ Hospital
Cincinnati, Ohio, United States
- Alexandru Costea, MD · Principal investigator
RecruitingUniversity of Cincinnati
Cincinnati, Ohio, United States
- Srinivas Rajsheker, MD · Principal investigator
RecruitingUniversity of Pennsylvania (UPENN)
Philadelphia, Pennsylvania, United States
- Benjamin D'Souza, MD · Principal investigator
RecruitingAllegheny Health
Pittsburgh, Pennsylvania, United States
- Joshua Silverstein, MD · Principal investigator
RecruitingCentra Health, Inc.dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
- Cindy Baumann · Contact
- Mathhew Sackett · Principal investigator
RecruitingBon Secours Medical Group - Richmond Specialty Care
Richmond, Virginia, United States
- An Bui, MD · Principal investigator
RecruitingValley Health System
Winchester, Virginia, United States
- Emmanuel Ekanem, MD · Principal investigator
RecruitingMulticare Health Systems-Pulse Heart
Puyallup, Washington, United States
- Tariq Salam, MD · Principal investigator
RecruitingFranciscan Heart and Vascular Associates
Tacoma, Washington, United States
- Nasir Shariff, MD · Principal investigator
RecruitingMercy Health
Janesville, Wisconsin, United States
- Kaitlyn Phetteplace · Contact
- Imdad Ahmed · Principal investigator
RecruitingNaples Community Hospital
Naples, Florida, United States
Withdrawn
Study team
Sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Study ID QDOT PAS
Study director
Brian Sanchez, MD
J & J Corporation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.