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Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
RECRUITINGSponsored by Heart Rhythm Clinical and Research Solutions, LLC
Actively Recruiting
SponsorHeart Rhythm Clinical and Research Solutions, LLC
Started2018-01-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations64 sites
View on ClinicalTrials.gov →
NCT04088071
Summary
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF * 18 years of age or older * De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry * Able and willing to participate in baseline and follow up evaluations for the full length of the registry * Willing and able to provide informed consent, if applicable Exclusion Criteria: * Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan * Long-standing persistent AF (AF greater than one year's duration) * Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry * In the opinion of the investigator, any known contraindication to an ablation procedure
Conditions3
Heart DiseaseParoxysmal Atrial FibrillationPersistent Atrial Fibrillation
Locations64 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Michelle Osoinak
Grandview Medical Center
Birmingham, Alabama, 35243
Susan Thorington
Cardiology Associates of Mobile
Mobile, Alabama, 36695
Lynn Ward
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Kayla Rubino
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Actively Recruiting
SponsorHeart Rhythm Clinical and Research Solutions, LLC
Started2018-01-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations64 sites
View on ClinicalTrials.gov →
NCT04088071