Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
NCT ID: NCT04088071
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15000 participants
OBSERVATIONAL
2018-01-01
2027-12-31
Brief Summary
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Detailed Description
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The objective of this registry is to assess clinical outcomes, including procedural efficiency, safety, long-term, effectiveness of RF ablations in the treatment of patients with Paroxysmal or Persistent atrial fibrillation. The outcomes of the registry are: 1) long term effectiveness defined as freedom from atrial arrhythmia recurrence post 90 day blanking period, and 2) acute and late onset complications.
Sites selected for this registry will already have the following pre and post procedure assessments as part of their standard of care:
Patient assessments at the following time points: (1) pre-ablation or baseline, (2) procedure, (3) 10-12 weeks, (4) 6 months (monitor only) and (5) 1 year post ablation.
Pre ablation/baseline assessment should include: TTE (within 6 months of procedure), CHADS2Vasc, sleep apnea, AAD status, OAC, Medical and Arrhythmia History 10-12 Week Follow-Up Office Visit: Physician evaluation, AAD status, OAC usage, repeat TTE, and Arrhythmia Reoccurrence and Treatment Assessment Monitoring: 96-hour continuous heart rhythm monitor scheduled at 6 months and 12 months post ablation, with an event monitor ordered as needed for symptomatic arrhythmias.
12 Month Follow up Office Visit: Physician evaluation, AF Type, AF Monitoring method, Sleep apnea, Post-procedure arrhythmia treatments, AF related symptoms and QOL improvement, AAD and OAC usage, CHA2DS2VASC and Arrhythmia Reoccurrence and Treatment Assessment
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Patients with atrial fibrillation
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.
Catheter ablation
Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).
Interventions
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Catheter ablation
Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Heart Rhythm Clinical and Research Solutions, LLC
OTHER
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Grandview Medical Center
Birmingham, Alabama, United States
Cardiology Associates of Mobile
Mobile, Alabama, United States
Valley Heart Rhythm Specialists
Chandler, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Keck School of Medicine
Los Angeles, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Community Memorial Hospital
Ventura, California, United States
University HealthCare Alliance
Walnut Creek, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Colorado Heart and Vascular
Golden, Colorado, United States
South Denver Cardiology
Littleton, Colorado, United States
Ascension St. Vincent's
Jacksonville, Florida, United States
HCA Florida Mercy Hospital
Miami, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Baycare Health System
Winter Haven, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Northshore University Health System
Evanston, Illinois, United States
Prairie Education and Research
Springfield, Illinois, United States
Ascension St. Vincent's Hospital
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Norton Heart Specialists
Louisville, Kentucky, United States
Baptist Health Louisville
Saint Matthews, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Capitol CArdiology
Lanham, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
McLaren Greater Lansing
Lansing, Michigan, United States
Sparrow Clinical Research
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Mississippi Baptist Medical Center
Jackson, Mississippi, United States
University of Missouri
Columbia, Missouri, United States
CoxHealth
Springfield, Missouri, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Lovelace Health System
Albuquerque, New Mexico, United States
Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)
New York, New York, United States
Nuvance Health
Poughkeepsie, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Mount Carmel Columbus Cardiology Consultants
Columbus, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
University of Pennsylvania, Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
Upstate Cardiology
Greenville, South Carolina, United States
Carolina Cardiology Associates and OnSite Clinical Solutions
Rock Hill, South Carolina, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
Centra Health, Inc. dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
Bon Secours St. Marys
Midlothian, Virginia, United States
CJW Medical Center
Richmond, Virginia, United States
Valley Health
Winchester, Virginia, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
MercyHealth
Janesville, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Alberta Health
Edmonton, Alberta, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Michelle Osoinak
Role: primary
Susan Thorington
Role: primary
Lynn Ward
Role: primary
Gianani Cabrera
Role: primary
Kayla Rubino
Role: primary
Silvia Perez
Role: primary
Jennifer Freeland
Role: primary
Chris Dutka
Role: primary
David Bailey
Role: primary
Kathy Siegel
Role: primary
Jasmine Vestal
Role: primary
Isabel Vital
Role: primary
Anessa B Diers
Role: primary
Ashley Corlies
Role: primary
Colleen Linder
Role: primary
Lynda Argenzio
Role: primary
Mariam Nuhu
Role: primary
Alta Castellino, BSN
Role: primary
Ritzie Anne Trinidad, MBA
Role: backup
Beth Blackburn
Role: primary
Marisa Durante
Role: primary
Magen Kaler
Role: primary
Anne Renick
Role: primary
Trisha Elliot
Role: primary
Tina Abell, RN, BSN
Role: primary
Karin Cryan
Role: primary
Joanne Burgess
Role: primary
Iluyomade Adeusi
Role: primary
Deborah Manuelian
Role: primary
Briita Wanhala
Role: primary
Jennifer Boak
Role: primary
Greg Schlosser
Role: primary
Elizabeth Goetz
Role: primary
Sherrina N. Dixon
Role: primary
Greta Beatty
Role: backup
Charles Donigian
Role: primary
Sam Atkinson
Role: primary
Kaitlyn Downey
Role: primary
Alexandra Ortiz
Role: primary
Olatunde Olaniyi
Role: primary
Alex Boyd
Role: primary
Patricia Reece
Role: primary
Stephanie Byrd
Role: primary
Anne Voorhorst
Role: primary
Elissa VanKirk
Role: primary
Terri Knight
Role: primary
Andrew Hershey
Role: primary
Katie Shoemaker
Role: primary
Caitlin Phalunas
Role: primary
Elayne Grim
Role: primary
Ericka Calhoun
Role: primary
Kristina Perez
Role: primary
Corryn Weatherred
Role: primary
Sherry Fisher
Role: primary
Cindy Baumann
Role: primary
Kelly Patterson
Role: primary
Ariana Dickens
Role: primary
Janie Simpson
Role: primary
Kari Davidson
Role: primary
Kaitlyn Phetteplace, MSN
Role: primary
Torrey Tiedman
Role: primary
Wei Chen
Role: primary
Lynn Nyman
Role: primary
References
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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.
Kreidieh 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.
Varley 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.
Osorio 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.
Kreidieh 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.
Costea 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.
Osorio 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.
Rajendra 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.
Rajendra 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.
Osorio 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.
Other Identifiers
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RAF
Identifier Type: -
Identifier Source: org_study_id
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