RecruitingNCT04088071

Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation

Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry


Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Enrollment

15,000 participants

Start Date

Jan 1, 2018

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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
  • 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 Criteria4

  • 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

Interventions

DEVICECatheter ablation

Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).


Locations(66)

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

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