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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, Alabama 35233
Contact:
Michelle Osoinak

Grandview Medical Center
Birmingham, Alabama 35243
Contact:
Susan Thorington

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

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

Arrhythmia Research Group
Jonesboro, Arkansas 72401
Contact:
Kayla Rubino

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

Community Memorial Hospital
Ventura, California 93303
Contact:
Jennifer Freeland

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

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

South Denver Cardiology
Littleton, Colorado 80120
Contact:
Kathy Siegel

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

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

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

Ascension Sacred Heart
Pensacola, Florida 32504
Contact:
Ashley Corlies

Sarasota Memorial Hospital
Sarasota, Florida 34239
Contact:
Colleen Linder

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

Piedmont Healthcare
Atlanta, Georgia 30309
Contact:
Mariam Nuhu

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

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

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

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

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

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

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

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

Maine Medical Center
Portland, Maine 04102
Contact:
Joanne Burgess

Capitol CArdiology
Lanham, Maryland 20706
Contact:
Iluyomade Adeusi

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

Henry Ford Health
Detroit, Michigan 48202
Contact:
Briita Wanhala

Sparrow Clinical Research
Lansing, Michigan 48912
Contact:
Jennifer Boak

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

Michigan Heart
Ypsilanti, Michigan 48197
Contact:
Elizabeth Goetz

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

University of Missouri
Columbia, Missouri 65212
Contact:
Charles Donigian

CoxHealth
Springfield, Missouri 65807
Contact:
Sam Atkinson

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

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

Nuvance Health
Poughkeepsie, New York 12601
Contact:
Olatunde Olaniyi

Mission Hospital
Asheville, North Carolina 28801
Contact:
Alex Boyd

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

University of Cincinnati
Cincinnati, Ohio 45202
Contact:
Stephanie Byrd

The Christ Hospital
Cincinnati, Ohio 45219
Contact:
Anne Voorhorst

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

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

Lancaster General Hospital
Lancaster, Pennsylvania 17602
Contact:
Andrew Hershey

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

Allegheny Health Network
Pittsburgh, Pennsylvania 15222
Contact:
Caitlin Phalunas

WellSpan Health
York, Pennsylvania 17403
Contact:
Elayne Grim

Upstate Cardiology
Greenville, South Carolina 29607
Contact:
Ericka Calhoun

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

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

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

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

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

CJW Medical Center
Richmond, Virginia 23261
Contact:
Ariana Dickens

Valley Health
Winchester, Virginia 22601
Contact:
Janie Simpson

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

MercyHealth
Janesville, Wisconsin 53548
Contact:
Kaitlyn Phetteplace, MSN

University of Wisconsin
Madison, Wisconsin 53792
Contact:
Torrey Tiedman

More Details

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

Study Contact

Kim Harbin
1-256-591-0727
kharbin@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.

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