Real-world experience of catheter ablation for atrial fibrillation
Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry
This study is trying to see how well catheter ablation works for treating atrial fibrillation in real-life settings and what the outcomes are for patients over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heart Rhythm Clinical and Research Solutions, LLC Academic / other |
| Locations | 66 sites (Birmingham, Alabama and 65 other locations) |
| Trial ID | NCT04088071 on ClinicalTrials.gov |
What this trial studies
This registry aims to gather real-world clinical data on the use of radiofrequency catheter ablation technologies for treating Paroxysmal and Persistent Atrial Fibrillation. It is an observational, prospective, multi-center registry that will assess clinical outcomes such as procedural efficiency, safety, and long-term effectiveness of the ablation procedures. Patient evaluations will occur at multiple time points, including pre-ablation, during the procedure, and at follow-up intervals of 10-12 weeks, 6 months, and 1 year post-ablation. The registry will also include assessments of complications and arrhythmia recurrence.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older with symptomatic Paroxysmal or Persistent Atrial Fibrillation who are considered suitable for ablation.
Not a fit: Patients with long-standing persistent Atrial Fibrillation or those enrolled in other investigational trials may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of catheter ablation for patients with atrial fibrillation.
How similar studies have performed: Other studies have shown success with similar observational approaches in assessing catheter ablation outcomes, indicating that this methodology is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 65 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Grandview Medical Center — Birmingham, Alabama, United States (Recruiting)
- Cardiology Associates of Mobile — Mobile, Alabama, United States (Recruiting)
- Valley Heart Rhythm Specialists — Chandler, Arizona, United States (Recruiting)
- Arrhythmia Research Group — Jonesboro, Arkansas, United States (Recruiting)
- Keck School of Medicine — Los Angeles, California, United States (Recruiting)
- Santa Barbara Cottage Hospital — Santa Barbara, California, United States (Terminated)
- Community Memorial Hospital — Ventura, California, United States (Recruiting)
- University HealthCare Alliance — Walnut Creek, California, United States (Completed)
- The Medical Center of Aurora — Aurora, Colorado, United States (Recruiting)
- Colorado Heart and Vascular — Golden, Colorado, United States (Recruiting)
- South Denver Cardiology — Littleton, Colorado, United States (Recruiting)
- Ascension St. Vincent's — Jacksonville, Florida, United States (Recruiting)
- HCA Florida Mercy Hospital — Miami, Florida, United States (Recruiting)
- Naples Community Hospital — Naples, Florida, United States (Recruiting)
- Ascension Sacred Heart — Pensacola, Florida, United States (Recruiting)
- Sarasota Memorial Hospital — Sarasota, Florida, United States (Recruiting)
- Baycare Health System — Winter Haven, Florida, United States (Recruiting)
- Piedmont Healthcare — Atlanta, Georgia, United States (Recruiting)
- Memorial Health University Medical Center — Savannah, Georgia, United States (Recruiting)
- The Queen's Medical Center — Honolulu, Hawaii, United States (Recruiting)
- Northshore University Health System — Evanston, Illinois, United States (Recruiting)
- Prairie Education and Research — Springfield, Illinois, United States (Recruiting)
- Ascension St. Vincent's Hospital — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Norton Heart Specialists — Louisville, Kentucky, United States (Recruiting)
- Baptist Health Louisville — Saint Matthews, Kentucky, United States (Recruiting)
- Maine Medical Center — Portland, Maine, United States (Recruiting)
- Capitol CArdiology — Lanham, Maryland, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- McLaren Greater Lansing — Lansing, Michigan, United States (Active_not_recruiting)
- Sparrow Clinical Research — Lansing, Michigan, United States (Recruiting)
- William Beaumont Hospital — Royal Oak, Michigan, United States (Recruiting)
- Michigan Heart — Ypsilanti, Michigan, United States (Recruiting)
- Mississippi Baptist Medical Center — Jackson, Mississippi, United States (Recruiting)
- University of Missouri — Columbia, Missouri, United States (Recruiting)
- CoxHealth — Springfield, Missouri, United States (Recruiting)
- Cardiovascular Associates of the Delaware Valley — Haddon Heights, New Jersey, United States (Recruiting)
- Lovelace Health System — Albuquerque, New Mexico, United States (Recruiting)
- Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH) — New York, New York, United States (Recruiting)
- Nuvance Health — Poughkeepsie, New York, United States (Recruiting)
- Mission Hospital — Asheville, North Carolina, United States (Recruiting)
- Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Mount Carmel Columbus Cardiology Consultants — Columbus, Ohio, United States (Recruiting)
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (Recruiting)
- Lancaster General Hospital — Lancaster, Pennsylvania, United States (Recruiting)
- University of Pennsylvania, Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
+16 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Jennifer White, MS
- Email: jwhite@hrcrs.com
- Phone: 1-629-335-8261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.