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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Catheter ablation
    Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35233
Contact:
Michelle Osoinak

Grandview Medical Center
Birmingham 4049979, Alabama 4829764 35243
Contact:
Susan Thorington

Cardiology Associates of Mobile
Mobile 4076598, Alabama 4829764 36695
Contact:
Lynn Ward

Valley Heart Rhythm Specialists
Chandler 5289282, Arizona 5551752 85224
Contact:
Gianani Cabrera

Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
Contact:
Kayla Rubino

Keck School of Medicine
Los Angeles 5368361, California 5332921 90033
Contact:
Silvia Perez

Community Memorial Hospital
Ventura 5405878, California 5332921 93303
Contact:
Jennifer Freeland

The Medical Center of Aurora
Aurora 5412347, Colorado 5417618 80012
Contact:
Chris Dutka

Colorado Heart and Vascular
Golden 5423294, Colorado 5417618 80401
Contact:
David Bailey

South Denver Cardiology
Littleton 5429032, Colorado 5417618 80120
Contact:
Kathy Siegel

Ascension St. Vincent's
Jacksonville 4160021, Florida 4155751 32204
Contact:
Jasmine Vestal

HCA Florida Mercy Hospital
Miami 4164138, Florida 4155751 33133
Contact:
Isabel Vital

Naples Community Hospital
Naples 4165565, Florida 4155751 34101
Contact:
Anessa B Diers

Ascension Sacred Heart
Pensacola 4168228, Florida 4155751 32504
Contact:
Ashley Corlies

Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
Contact:
Colleen Linder

Baycare Health System
Winter Haven 4178552, Florida 4155751 33881
Contact:
Lynda Argenzio

Piedmont Healthcare
Atlanta 4180439, Georgia 4197000 30309
Contact:
Mariam Nuhu

Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000 31404
Contact:
Alta Castellino, BSN

The Queen's Medical Center
Honolulu 5856195, Hawaii 5855797 97813
Contact:
Beth Blackburn

Northshore University Health System
Evanston 4891382, Illinois 4896861 60201
Contact:
Marisa Durante

Prairie Education and Research
Springfield 4250542, Illinois 4896861 62704
Contact:
Magen Kaler

Ascension St. Vincent's Hospital
Indianapolis 4259418, Indiana 4921868 46260
Contact:
Anne Renick

University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Contact:
Trisha Elliot

Norton Heart Specialists
Louisville 4299276, Kentucky 6254925 40205
Contact:
Tina Abell, RN, BSN

Baptist Health Louisville
Saint Matthews 4307238, Kentucky 6254925 40207
Contact:
Karin Cryan

Maine Medical Center
Portland 4975802, Maine 4971068 04102
Contact:
Joanne Burgess

Capitol CArdiology
Lanham 4360321, Maryland 4361885 20706
Contact:
Iluyomade Adeusi

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Deborah Manuelian
617-732-5087

Henry Ford Health
Detroit 4990729, Michigan 5001836 48202
Contact:
Briita Wanhala

Sparrow Clinical Research
Lansing 4998830, Michigan 5001836 48912
Contact:
Jennifer Boak

William Beaumont Hospital
Royal Oak 5007804, Michigan 5001836 48073
Contact:
Greg Schlosser

Michigan Heart
Ypsilanti 5015688, Michigan 5001836 48197
Contact:
Elizabeth Goetz

Mississippi Baptist Medical Center
Jackson 4431410, Mississippi 4436296 39202
Contact:
Sherrina N. Dixon

University of Missouri
Columbia 4381982, Missouri 4398678 65212
Contact:
Charles Donigian

CoxHealth
Springfield 4409896, Missouri 4398678 65807
Contact:
Sam Atkinson

Cardiovascular Associates of the Delaware Valley
Haddon Heights 4502093, New Jersey 5101760 08035
Contact:
Kaitlyn Downey

Lovelace Health System
Albuquerque 5454711, New Mexico 5481136 87102
Contact:
Alexandra Ortiz

Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)
New York 5128581, New York 5128638 10032
Contact:
Kate Dalton
347-514-3666
keb2114@cumc.columbia.edu

Nuvance Health
Poughkeepsie 5132143, New York 5128638 12601
Contact:
Olatunde Olaniyi

Mission Hospital
Asheville 4453066, North Carolina 4482348 28801
Contact:
Alex Boyd

Novant Health Forsyth Medical Center
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
Patricia Reece

University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45202
Contact:
Stephanie Byrd

The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Anne Voorhorst

Mount Carmel Columbus Cardiology Consultants
Columbus 4509177, Ohio 5165418 43213
Contact:
Elissa VanKirk
614-546-4327

Oklahoma Heart Hospital
Oklahoma City 4544349, Oklahoma 4544379 73120
Contact:
Terri Knight

Lancaster General Hospital
Lancaster 5197079, Pennsylvania 6254927 17602
Contact:
Andrew Hershey

University of Pennsylvania, Penn Presbyterian Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Katie Shoemaker

Allegheny Health Network
Pittsburgh 5206379, Pennsylvania 6254927 15222
Contact:
Caitlin Phalunas

WellSpan Health
York 4562407, Pennsylvania 6254927 17403
Contact:
Elayne Grim

Upstate Cardiology
Greenville 4580543, South Carolina 4597040 29607
Contact:
Ericka Calhoun

Baylor Scott & White Research Institute
Dallas 4684888, Texas 4736286 75204
Contact:
Kristina Perez

Medical City Dallas Hospital
Dallas 4684888, Texas 4736286 75320
Contact:
Corryn Weatherred

St. Mark's Hospital
Salt Lake City 5780993, Utah 5549030 84124
Contact:
Sherry Fisher

Centra Health, Inc. dba Stroobants Cardiovascular Center
Lynchburg 4771075, Virginia 6254928 24501
Contact:
Cindy Baumann

Bon Secours St. Marys
Midlothian 4772943, Virginia 6254928 23114
Contact:
Kelly Patterson

CJW Medical Center
Richmond 4781708, Virginia 6254928 23261
Contact:
Ariana Dickens

Valley Health
Winchester 4794120, Virginia 6254928 22601
Contact:
Janie Simpson

MultiCare Institute for Research & Innovation
Tacoma 5812944, Washington 5815135 98405
Contact:
Kari Davidson

MercyHealth
Janesville 5257754, Wisconsin 5279468 53548
Contact:
Kaitlyn Phetteplace, MSN

University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792
Contact:
Torrey Tiedman

More Details

NCT ID
NCT04088071
Status
Recruiting
Sponsor
Heart Rhythm Clinical and Research Solutions, LLC

Study Contact

Jennifer White, MS
1-629-335-8261
jwhite@hrcrs.com

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

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