Clinical trial NCT04088071: Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Official title: Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2019-09-12
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation.

Brief 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.

Detailed description: The REAL AF Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of Paroxysmal and Persistent ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF). Future new contact force technologies may be included as they become available in the market. Patient assessments will occur at the following time points: 1) pre-ablation, 2) procedure, 3) 10-12 weeks, 4) 6 months (monitor only) and 5) 1 year post ablation.

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

Eligibility 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

Primary outcomes:
measure: Effectiveness at 90 days
timeFrame: 90 days
measure: Effectiveness at 12 months
timeFrame: 12 months
measure: Long-term Safety
timeFrame: Post-procedure, 3 months, and 12 months
Secondary outcomes:
measure: AF recurrence
timeFrame: 12 months
measure: Post-procedure arrhythmia treatments
timeFrame: 12 months
measure: AF related symptoms
timeFrame: 12 months
measure: AAD Usage
timeFrame: 12 months
measure: OAC usage
timeFrame: 12 months
measure: CHA2DS2VASC
timeFrame: 12 months
measure: Patient reported outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Mobile
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Chandler
country: United States
facility: Valley Heart Rhythm Specialists
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Los Angeles
country: United States
facility: Keck School of Medicine
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Ventura
country: United States
facility: Community Memorial Hospital
state: California
city: Walnut Creek
country: United States
facility: University HealthCare Alliance
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Golden
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology
state: Colorado
city: Jacksonville
country: United States
facility: Ascension St. Vincent's
state: Florida
city: Miami
country: United States
facility: HCA Florida Mercy Hospital
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Winter Haven
country: United States
facility: Baycare Health System
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research
state: Illinois
city: Indianapolis
country: United States
facility: Ascension St. Vincent's Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: Norton Heart Specialists
state: Kentucky
city: Saint Matthews
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Lanham
country: United States
facility: Capitol CArdiology
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Lansing
country: United States
facility: McLaren Greater Lansing
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Jackson
country: United States
facility: Mississippi Baptist Medical Center
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Springfield
country: United States
facility: CoxHealth
state: Missouri
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Health System
state: New Mexico
city: Poughkeepsie
country: United States
facility: Nuvance Health
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Columbus Cardiology Consultants
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania, Penn Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Cardiology
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Cardiology Associates and OnSite Clinical Solutions
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
city: Lynchburg
country: United States
facility: Centra Health, Inc. dba Stroobants Cardiovascular Center
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St. Marys
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center
state: Virginia
city: Winchester
country: United States
facility: Valley Health
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Janesville
country: United States
facility: MercyHealth
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Alberta Health
state: Alberta
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.