Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
REAL Registry
1 other identifier
observational
20,000
2 countries
70
Brief Summary
The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA. The Registry will utilize real world clinical data obtained from the use of commercially available CARTO™ technologies under the authority of a health care practitioner within a legitimate practitioner-subject relationship. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with novel technologies for arrhythmia patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 9, 2026
July 1, 2026
11 years
August 26, 2019
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Effectiveness at 90 days
Freedom from arrhythmia recurrence at 90 days post procedure.
90 days
Effectiveness at 12 months
Freedom from subject reported arrhythmia recurrence through 12 months post procedure.
12 months
Long-term Safety
Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related
30 days post ablation
Secondary Outcomes (7)
Arrhythmia recurrence
12 months
Post-procedure arrhythmia treatments
12 months
Arrhythmia related symptoms
12 months
AAD Usage
12 months
OAC usage
12 months
- +2 more secondary outcomes
Study Arms (2)
REAL AF
Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements.
CORE VA
Subjects with documented ventricular arrhythmia appropriate for catheter ablation, greater than 18 years of age, will be treated with Biosense Webster Inc. ablation technologies, and are willing and able to participate in baseline and follow up evaluations.
Interventions
Ablation using Biosense Webster, Inc. (BWI) CARTO™ technologies (e.g., THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available.
Eligibility Criteria
Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation in the REAL AF Cohort and adults age 18 years or older with documented ventricular arrhythmia appropriate for catheter ablation in the CORE VA Cohort.
You may qualify if:
- Symptomatic PAF (AF episode terminate spontaneously within 7 days) or PsAF (AF sustained beyond 7 days, but less than 365 days) subjects who, in the opinion of the investigator, are candidates for catheter ablation.
- \>18 years of age.
- Will be treated with Biosense Webster Inc. ablation technologies
- All AF ablations performed with BWI catheters are included. This includes repeat ablations where the index procedure was performed with a non-BWI catheter.
- Able and willing to participate in baseline and follow up evaluations
- Willing and able to provide informed consent, if applicable.
You may not qualify if:
- 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)
- In the opinion of the investigator, any known contraindication to an ablation procedure
- CORE VA Cohort
- Documented ventricular arrhythmia appropriate for catheter ablation.
- \>18 years of age.
- Will be treated with Biosense Webster Inc. ablation technologies
- Able and willing to participate in baseline and follow up evaluations
- Willing and able to provide informed consent, if applicable.
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
- In the opinion of the investigator, any known contraindication to an ablation procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Grandview Medical Center
Birmingham, Alabama, 35243, United States
Cardiology Associates of Mobile
Mobile, Alabama, 36695, United States
Valley Heart Rhythm Specialists
Chandler, Arizona, 85224, United States
Pima Heart and Vascular
Tucson, Arizona, 85741, United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Keck School of Medicine
Los Angeles, California, 90033, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Community Memorial Hospital
Ventura, California, 93303, United States
University HealthCare Alliance
Walnut Creek, California, 94598, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Colorado Heart and Vascular
Golden, Colorado, 80401, United States
South Denver Cardiology
Littleton, Colorado, 80120, United States
Ascension St. Vincent's
Jacksonville, Florida, 32204, United States
HCA Florida Mercy Hospital
Miami, Florida, 33133, United States
Naples Community Hospital
Naples, Florida, 34101, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Baycare Health Tampa
Tampa, Florida, 33606, United States
Baycare Health System
Winterhaven, Florida, 33881, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
The Queen's Medical Center
Honolulu, Hawaii, 97813, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
Midwest Cardiovascular Institute
Naperville, Illinois, 60540, United States
Prairie Education and Research
Springfield, Illinois, 62704, United States
Ascension St. Vincent's Hospital
Indianapolis, Indiana, 46260, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Norton Heart Specialists
Louisville, Kentucky, 40205, United States
Baptist Health Louisville
Saint Matthews, Kentucky, 40207, United States
Maine Medical Center
Portland, Maine, 04102, United States
Capitol CArdiology
Lanham, Maryland, 20706, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
McLaren Greater Lansing
Lansing, Michigan, 48910, United States
Sparrow Clinical Research
Lansing, Michigan, 48912, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Mississippi Baptist Medical Center
Jackson, Mississippi, 39202, United States
University of Missouri
Columbia, Missouri, 65212, United States
CoxHealth
Springfield, Missouri, 65807, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035, United States
Lovelace Health System
Albuquerque, New Mexico, 87102, United States
Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)
New York, New York, 10032, United States
Nuvance Health
Poughkeepsie, New York, 12601, United States
Crouse Health System and Crouse Medical Practice
Syracuse, New York, 13210, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati
Cincinnati, Ohio, 45202, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Mount Carmel Columbus Cardiology Consultants
Columbus, Ohio, 43213, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
University of Pennsylvania, Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15222, United States
WellSpan Health
York, Pennsylvania, 17403, United States
Upstate Cardiology
Greenville, South Carolina, 29607, United States
Carolina Cardiology Associates and OnSite Clinical Solutions
Rock Hill, South Carolina, 29732, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
Medical City Dallas Hospital
Dallas, Texas, 75320, United States
St. Mark's Hospital
Salt Lake City, Utah, 84124, United States
Centra Health, Inc. dba Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Bon Secours St. Marys
Midlothian, Virginia, 23114, United States
CJW Medical Center
Richmond, Virginia, 23261, United States
Valley Health
Winchester, Virginia, 22601, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
MercyHealth
Janesville, Wisconsin, 53548, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Alberta Health
Edmonton, Alberta, T6G2B7, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y2P6, Canada
Related Publications (10)
Sharma E, Varley A, Osorio J, Thorne C, Varosy P, Metzl M, Rajendra A, Oza S, Morales G, Magnano A, D'Souza B, Sackett M, Sellers M, Silva J, Silverstein J, Ho J, Hoskins M, Kuk R, Romero J, Zei PC. Procedural Trends in Catheter Ablation of Persistent Atrial Fibrillation: Insights From the Real-AF Registry. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011828. doi: 10.1161/CIRCEP.123.011828. Epub 2023 May 31. No abstract available.
PMID: 37254771BACKGROUNDKreidieh O, Varley AL, Romero J, Singh D, Silverstein J, Thosani A, Varosy P, Hebsur S, Godfrey BE, Schrappe G, Justice L, Zei PC, Osorio J. Practice Patterns of Operators Participating in the Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL-AF) Registry. J Interv Card Electrophysiol. 2022 Nov;65(2):429-440. doi: 10.1007/s10840-022-01205-0. Epub 2022 Apr 19.
PMID: 35438393BACKGROUNDVarley AL, Kreidieh O, Godfrey BE, Whitmire C, Thorington S, D'Souza B, Kang S, Hebsur S, Ravindran BK, Zishiri E, Gidney B, Sellers MB, Singh D, Salam T, Metzl M, Ro A, Nazari J, Fisher WG, Costea A, Magnano A, Oza S, Morales G, Rajendra A, Silverstein J, Zei PC, Osorio J. A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives. J Interv Card Electrophysiol. 2021 Dec;62(3):487-494. doi: 10.1007/s10840-021-01031-w. Epub 2021 Jul 2.
PMID: 34212280BACKGROUNDOsorio J, Miranda-Arboleda AF, Velasco A, Varley AL, Rajendra A, Morales GX, Hoyos C, Matos C, Thorne C, D'Souza B, Silverstein JR, Metzl MD, Hebsur S, Costea AI, Kang S, Sellers M, Singh D, Salam T, Nazari J, Ro AS, Mazer S, Moretta A, Oza SR, Magnano AR, Sackett M, Dukes J, Patel P, Goyal SK, Senn T, Newton D, Romero JE, Zei PC; REAL-AF Investigators. Real-world data of radiofrequency catheter ablation in paroxysmal atrial fibrillation: Short- and long-term clinical outcomes from the prospective multicenter REAL-AF Registry. Heart Rhythm. 2024 Nov;21(11):2083-2091. doi: 10.1016/j.hrthm.2024.04.090. Epub 2024 May 19.
PMID: 38768839RESULTKreidieh O, Hunter TD, Goyal S, Varley AL, Thorne C, Osorio J, Silverstein J, Varosy P, Metzl M, Leyton-Mange J, Singh D, Rajendra A, Moretta A, Zei PC; Investigators of the REAL AF registry. Predictors of first pass isolation of the pulmonary veins in real world ablations: An analysis of 2671 patients from the REAL-AF registry. J Cardiovasc Electrophysiol. 2024 Mar;35(3):440-450. doi: 10.1111/jce.16190. Epub 2024 Jan 28.
PMID: 38282445RESULTCostea A, Diaz JC, Osorio J, Matos CD, Hoyos C, Goyal S, Te C, D'Souza B, Rastogi M, Lopez-Cabanillas N, Ibanez LC, Thorne C, Varley AL, Zei PC, Sauer WH, Romero JE. 50-W vs 40-W During High-Power Short-Duration Ablation for Paroxysmal Atrial Fibrillation: A Multicenter Prospective Study. JACC Clin Electrophysiol. 2023 Dec;9(12):2573-2583. doi: 10.1016/j.jacep.2023.08.005. Epub 2023 Oct 4.
PMID: 37804258RESULTOsorio J, Zei PC, Diaz JC, Varley AL, Morales GX, Silverstein JR, Oza SR, D'Souza B, Singh D, Moretta A, Metzl MD, Hoyos C, Matos CD, Rivera E, Magnano A, Salam T, Nazari J, Thorne C, Costea A, Thosani A, Rajendra A, Romero JE. High-Frequency Low-Tidal Volume Ventilation Improves Long-Term Outcomes in AF Ablation: A Multicenter Prospective Study. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1543-1554. doi: 10.1016/j.jacep.2023.05.015. Epub 2023 May 18.
PMID: 37294263RESULTRajendra A, Osorio J, Diaz JC, Hoyos C, Rivera E, Matos CD, Costea A, Varley AL, Thorne C, Hoskins M, Goyal S, Oza S, Magnano A, D'Souza B, Silverstein J, Metzl M, Zei PC, Romero JE. Performance of the REAL-AF Same-Day Discharge Protocol in Patients Undergoing Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1515-1526. doi: 10.1016/j.jacep.2023.04.014. Epub 2023 May 18.
PMID: 37204358RESULTRajendra A, Hunter TD, Morales GX, Zei P, Boo LM, Varley A, Osorio J. Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol. 2023 Mar;66(2):381-388. doi: 10.1007/s10840-022-01332-8. Epub 2022 Aug 10.
PMID: 35947317RESULTOsorio J, Varley A, Kreidieh O, Godfrey B, Schrappe G, Rajendra A, Silverstein J, Romero J, Rodriguez D, Morales G, Zei P. High-Frequency, Low-Tidal-Volume Mechanical Ventilation Safely Improves Catheter Stability and Procedural Efficiency During Radiofrequency Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010722. doi: 10.1161/CIRCEP.121.010722. Epub 2022 Mar 25. No abstract available.
PMID: 35333095RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
September 12, 2019
Study Start
January 1, 2018
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
July 9, 2026
Record last verified: 2026-07