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Erfaring fra den virkelige verden med kateterablation til behandling af paroxysmal og vedvarende atrieflimren (REAL Registry)

17. september 2026 opdateret af: Heart Rhythm Clinical and Research Solutions, LLC

Erfaring fra den virkelige verden med kateterablation til behandling af symptomatisk paroxysmal og vedvarende atrieflimren ved brug af nye Contact Force-teknologier: REAL AF Registry

The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA. The Registry will utilize real world clinical data obtained from the use of commercially available CARTO™ technologies under the authority of a health care practitioner within a legitimate practitioner-subject relationship. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with novel technologies for arrhythmia patients.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Enhed: Catheter ablation

Detaljeret beskrivelse

The REAL Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of ablation using Biosense Webster, Inc. (BWI) CARTO technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available.

Current clinical practice guidelines recommend ablation for ventricular arrhythmias (VA) and atrial fibrillation (AF)1,2. Therefore, REAL AF will include subjects with symptomatic paroxysmal AF (PAF), persistent AF (PsAF) who meet all eligibility criteria and in the opinion of the investigator, are candidates for AF catheter ablation. CORE-VA will include all subjects with documented ventricular arrhythmia appropriate for catheter ablation.

All subjects will be treated with commercially approved BWI ablation catheters, and the ablation procedure will be conducted based on the participating Site's current standard of care (SOC). Participation in the Registry does not influence treatment decisions. All consecutive subjects presenting at the Site considered for an ablation procedure should be screened by the Investigator or a designated member of the research team for eligibility.

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 Arrhythmia recurrence post 90-day blanking period, 2) acute safety defined by serious complications within 7 days post ablation and up to 30 days post ablation.

Sites and Investigators considered for inclusion in the Registry will be assessed to determine if their practice patterns align, minimally, with what is outlined in VISIT SCHEDULE AND DATA COLLECTION of this protocol for the specific cohort in which the investigators will be enrolling. Investigators need to only align with the requirements of one cohort, but can participate in both, if qualified, and selected in each cohort. The Registry does not require any additional visits above what is considered standard of care follow-up for the Registry subject population.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

20000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Jose Osorio, MD
E-mail: josorio@hrcrs.com

Undersøgelse Kontakt Backup

Navn: April Bond, MS
Telefonnummer: 1-901-828-5707
E-mail: abond@hrcrs.com

Studiesteder

Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G2B7
    - Rekruttering
    - Alberta Health
    - Kontakt:
      
      Wei Chen
    - Ledende efterforsker:
      
      Kenneth Quadros, MD
- Ontario
  - Kitchener, Ontario, Canada, N2M 5N6
    - Rekruttering
    - Waterloo Wellington Cardiovascular Research Institute
    - Ledende efterforsker:
      
      Umjeet Jolly, MD
    - Kontakt:
      
      Mary Radyk
      
      E-mail: mradyk@wwcri.ca
  - Newmarket, Ontario, Canada, L3Y2P6
    - Rekruttering
    - Southlake Regional Health Centre
    - Ledende efterforsker:
      
      Yaariv Khaykin, MD
    - Kontakt:
      
      Lynn Nyman
- Quebec
  - Montreal, Quebec, Canada, H1T 1C8
    - Rekruttering
    - Montreal Heart Institute
    - Kontakt:
      
      Caroline Girard
      
      E-mail: caroline.girard@icm-mhi.org
    - Ledende efterforsker:
      
      Martin Aguilar, MD
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35233
    - Rekruttering
    - University of Alabama at Birmingham
    - Ledende efterforsker:
      
      William Maddox, MD
    - Kontakt:
      
      Michelle Osoinak
  - Birmingham, Alabama, Forenede Stater, 35243
    - Rekruttering
    - Grandview Medical Center
    - Underforsker:
      
      Gustavo Morales, MD
    - Ledende efterforsker:
      
      Anil Rajendra, MD
    - Kontakt:
      
      Susan Thorington
  - Mobile, Alabama, Forenede Stater, 36695
    - Rekruttering
    - Cardiology Associates of Mobile
    - Ledende efterforsker:
      
      Matthew Quin, MD
    - Kontakt:
      
      Lynn Ward
- Arizona
  - Chandler, Arizona, Forenede Stater, 85224
    - Rekruttering
    - Valley Heart Rhythm Specialists
    - Ledende efterforsker:
      
      Huy Phan, MD
    - Kontakt:
      
      Gianani Cabrera
  - Tucson, Arizona, Forenede Stater, 85741
    - Rekruttering
    - Pima Heart and Vascular
    - Kontakt:
      
      Monica Varela
      
      Telefonnummer: 5209756400
      
      E-mail: monica.varela@usheartandvascular.com
    - Ledende efterforsker:
      
      Jitender Munjal, MD
- Arkansas
  - Jonesboro, Arkansas, Forenede Stater, 72401
    - Rekruttering
    - Arrhythmia Research Group
    - Ledende efterforsker:
      
      Devi Nair, MD
    - Kontakt:
      
      Kayla Rubino
- California
  - Los Angeles, California, Forenede Stater, 90033
    - Rekruttering
    - Keck School of Medicine
    - Kontakt:
      
      Silvia Perez
    - Ledende efterforsker:
      
      Ivan Ho, MD
    - Underforsker:
      
      Junaid Zaman, PhD, MD
    - Underforsker:
      
      Andrew Zadeh, MD
    - Underforsker:
      
      Steven Leung, MD
  - Santa Barbara, California, Forenede Stater, 93105
    - Afsluttet
    - Santa Barbara Cottage Hospital
  - Ventura, California, Forenede Stater, 93303
    - Rekruttering
    - Community Memorial Hospital
    - Kontakt:
      
      Jennifer Freeland
    - Ledende efterforsker:
      
      Jonathan Dukes, MD
  - Walnut Creek, California, Forenede Stater, 94598
    - Afsluttet
    - University HealthCare Alliance
- Colorado
  - Aurora, Colorado, Forenede Stater, 80012
    - Rekruttering
    - The Medical Center of Aurora
    - Kontakt:
      
      Chris Dutka
    - Ledende efterforsker:
      
      Christopher Porterfield, MD
  - Golden, Colorado, Forenede Stater, 80401
    - Rekruttering
    - Colorado Heart and Vascular
    - Kontakt:
      
      David Bailey
  - Littleton, Colorado, Forenede Stater, 80120
    - Rekruttering
    - South Denver Cardiology
    - Kontakt:
      
      Kathy Siegel
    - Ledende efterforsker:
      
      Daniel Alyesh, MD
- Florida
  - Jacksonville, Florida, Forenede Stater, 32204
    - Rekruttering
    - Ascension St. Vincent's
    - Ledende efterforsker:
      
      Saumil Oza, MD
    - Kontakt:
      
      Jasmine Vestal
    - Underforsker:
      
      Anthony Magnano, MD
  - Miami, Florida, Forenede Stater, 33133
    - Rekruttering
    - HCA Florida Mercy Hospital
    - Ledende efterforsker:
      
      Jose Osorio, MD
    - Kontakt:
      
      Isabel Vital
  - Naples, Florida, Forenede Stater, 34101
    - Rekruttering
    - Naples Community Hospital
    - Kontakt:
      
      Anessa B Diers
    - Ledende efterforsker:
      
      Dinesh Sharma, MD
  - Pensacola, Florida, Forenede Stater, 32504
    - Rekruttering
    - Ascension Sacred Heart
    - Kontakt:
      
      Ashley Corlies
    - Ledende efterforsker:
      
      Asim Ahmed, DO
  - Sarasota, Florida, Forenede Stater, 34239
    - Rekruttering
    - Sarasota Memorial Hospital
    - Kontakt:
      
      Colleen Linder
    - Ledende efterforsker:
      
      Antonio Moretta, MD
  - Tampa, Florida, Forenede Stater, 33606
    - Rekruttering
    - Baycare Health Tampa
    - Kontakt:
      
      Christian Kelbaugh
      
      Telefonnummer: 8132548055
      
      E-mail: christian.kelbaugh@baycare.org
    - Ledende efterforsker:
      
      Shalin Shah, MD
  - Winterhaven, Florida, Forenede Stater, 33881
    - Rekruttering
    - Baycare Health System
    - Ledende efterforsker:
      
      Rodrigo Bolanos, MD
    - Kontakt:
      
      Lynda Argenzio
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30309
    - Rekruttering
    - Piedmont Healthcare
    - Ledende efterforsker:
      
      Sandeep Goyal, MD
    - Underforsker:
      
      Michael Hoosien, MD
    - Underforsker:
      
      Ashish Bhimani, MD
    - Underforsker:
      
      Kavita Krishnasamy, MD
    - Kontakt:
      
      Mariam Nuhu
  - Savannah, Georgia, Forenede Stater, 31404
    - Rekruttering
    - Memorial Health University Medical Center
    - Kontakt:
      
      Alta Castellino, BSN
    - Kontakt:
      
      Ritzie Anne Trinidad, MBA
    - Ledende efterforsker:
      
      David Newton, MD
    - Underforsker:
      
      Todd Senn, MD
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 97813
    - Afsluttet
    - The Queen's Medical Center
- Illinois
  - Evanston, Illinois, Forenede Stater, 60201
    - Rekruttering
    - Northshore University Health System
    - Ledende efterforsker:
      
      Mark Metzl, MD
    - Underforsker:
      
      Jose Nazari, MD
    - Underforsker:
      
      Alex Ro, MD
    - Kontakt:
      
      Marisa Durante
    - Underforsker:
      
      Jeremiah Wasserlauf, MD
  - Naperville, Illinois, Forenede Stater, 60540
    - Rekruttering
    - Midwest Cardiovascular Institute
    - Kontakt:
      
      Sherri McCoy
      
      Telefonnummer: 630-600-0700
      
      E-mail: sherri.mccoy@cardio.com
    - Ledende efterforsker:
      
      Kousik Krishnan, MD
  - Springfield, Illinois, Forenede Stater, 62704
    - Rekruttering
    - Prairie Education and Research
    - Underforsker:
      
      Suresh Kulandhaisamy, MD
    - Kontakt:
      
      Magen Kaler
    - Ledende efterforsker:
      
      Paban Saha, MD
    - Underforsker:
      
      Michael Hushion, MD
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46260
    - Rekruttering
    - Ascension St. Vincent's Hospital
    - Ledende efterforsker:
      
      Parin Patel, MD
    - Kontakt:
      
      Anne Renick
- Iowa
  - Iowa City, Iowa, Forenede Stater, 52242
    - Rekruttering
    - University of Iowa
    - Ledende efterforsker:
      
      Paari Dominic, MD
    - Kontakt:
      
      Trisha Elliot
- Kentucky
  - Louisville, Kentucky, Forenede Stater, 40205
    - Rekruttering
    - Norton Heart Specialists
    - Ledende efterforsker:
      
      Kent Morris, MD
    - Underforsker:
      
      Kevin Thomas, MD
    - Underforsker:
      
      Hassan Khan, MD
    - Kontakt:
      
      Tina Abell, RN, BSN
  - Saint Matthews, Kentucky, Forenede Stater, 40207
    - Rekruttering
    - Baptist Health Louisville
    - Kontakt:
      
      Karin Cryan
    - Ledende efterforsker:
      
      Kevin Parrott, MD
- Maine
  - Portland, Maine, Forenede Stater, 04102
    - Rekruttering
    - Maine Medical Center
    - Kontakt:
      
      Joanne Burgess
    - Ledende efterforsker:
      
      Jordan Leyton-Mange, MD
    - Underforsker:
      
      Andrew Corsello, MD
    - Underforsker:
      
      Henry Sesselberg, MD
    - Underforsker:
      
      Edwin Sze, MD
    - Underforsker:
      
      Kunal Tandon, MD
- Maryland
  - Lanham, Maryland, Forenede Stater, 20706
    - Rekruttering
    - Capitol CArdiology
    - Kontakt:
      
      Iluyomade Adeusi
    - Ledende efterforsker:
      
      Mohit Rastogi, MD
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - Rekruttering
    - Brigham and Women's Hospital
    - Underforsker:
      
      Jorge Romero, MD
    - Ledende efterforsker:
      
      Paul Zei, MD, PhD
    - Underforsker:
      
      Nathaniel Steiger, MD
    - Underforsker:
      
      Thomas Tadros, MD
    - Kontakt:
      
      Deborah Manuelian
      
      Telefonnummer: 617-732-5087
- Michigan
  - Detroit, Michigan, Forenede Stater, 48202
    - Rekruttering
    - Henry Ford Health
    - Kontakt:
      
      Briita Wanhala
    - Ledende efterforsker:
      
      Arfaat Khan, MD
  - Lansing, Michigan, Forenede Stater, 48910
    - Aktiv, ikke rekrutterende
    - McLaren Greater Lansing
  - Lansing, Michigan, Forenede Stater, 48912
    - Rekruttering
    - Sparrow Clinical Research
    - Kontakt:
      
      Jennifer Boak
    - Ledende efterforsker:
      
      Ali Sheikh, MD
  - Royal Oak, Michigan, Forenede Stater, 48073
    - Rekruttering
    - William Beaumont Hospital
    - Ledende efterforsker:
      
      Brian Williamson, MD
    - Kontakt:
      
      Greg Schlosser
  - Ypsilanti, Michigan, Forenede Stater, 48197
    - Rekruttering
    - Michigan Heart
    - Underforsker:
      
      Andrew Hughey, MD
    - Kontakt:
      
      Elizabeth Goetz
    - Underforsker:
      
      Mohammed-Ali Jazayeri, MD
    - Ledende efterforsker:
      
      Mohammad-Ali Jazayeri, MD
- Mississippi
  - Jackson, Mississippi, Forenede Stater, 39202
    - Rekruttering
    - Mississippi Baptist Medical Center
    - Kontakt:
      
      Sherrina N. Dixon
    - Kontakt:
      
      Greta Beatty
    - Ledende efterforsker:
      
      Adam Berman, MD
- Missouri
  - Columbia, Missouri, Forenede Stater, 65212
    - Rekruttering
    - University of Missouri
    - Kontakt:
      
      Charles Donigian
    - Ledende efterforsker:
      
      Sandeep Gautam, MD
    - Underforsker:
      
      Rahul Jain, MD
  - Springfield, Missouri, Forenede Stater, 65807
    - Rekruttering
    - CoxHealth
    - Kontakt:
      
      Sam Atkinson
    - Ledende efterforsker:
      
      John Garner, MD
    - Underforsker:
      
      Scott Ferreira, MD
- New Jersey
  - Haddon Heights, New Jersey, Forenede Stater, 08035
    - Rekruttering
    - Cardiovascular Associates of the Delaware Valley
    - Ledende efterforsker:
      
      George Mark, MD
    - Underforsker:
      
      Steven Levi, MD
    - Kontakt:
      
      Kaitlyn Downey
    - Underforsker:
      
      John Costello, DO
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87102
    - Rekruttering
    - Lovelace Health System
    - Underforsker:
      
      Michael Bestawros, MD
    - Ledende efterforsker:
      
      Sean Mazer, MD
    - Underforsker:
      
      Michael Hoskins, MD
    - Underforsker:
      
      Yaw Adej-Poku, MD
    - Underforsker:
      
      Sandeep Nair, MD
    - Kontakt:
      
      Alexandra Ortiz
- New York
  - New York, New York, Forenede Stater, 10032
    - Rekruttering
    - Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)
    - Kontakt:
      
      Kate Dalton
      
      Telefonnummer: 347-514-3666
      
      E-mail: keb2114@cumc.columbia.edu
    - Ledende efterforsker:
      
      Angelo Biviano, MD
  - Poughkeepsie, New York, Forenede Stater, 12601
    - Rekruttering
    - Nuvance Health
    - Kontakt:
      
      Olatunde Olaniyi
    - Ledende efterforsker:
      
      David Steckman, MD
  - Syracuse, New York, Forenede Stater, 13210
    - Rekruttering
    - Crouse Health System and Crouse Medical Practice
    - Kontakt:
      
      Jennifer Peterson
      
      Telefonnummer: 3154707111
      
      E-mail: jenniferapeterson@crousemed.com
    - Ledende efterforsker:
      
      Nikhil Joshi, MD
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28801
    - Rekruttering
    - Mission Hospital
    - Kontakt:
      
      Alex Boyd
    - Ledende efterforsker:
      
      Jason Lappe, MD
    - Underforsker:
      
      Michael Manogue, MD
    - Underforsker:
      
      John Brandt, MD
    - Underforsker:
      
      Zachary Hale, MD
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - Rekruttering
    - Novant Health Forsyth Medical Center
    - Kontakt:
      
      Patricia Reece
    - Ledende efterforsker:
      
      Nicholas Costa, MD
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Rekruttering
    - The Christ Hospital
    - Ledende efterforsker:
      
      Alexandru Costea, MD
    - Kontakt:
      
      Anne Voorhorst
  - Cincinnati, Ohio, Forenede Stater, 45202
    - Rekruttering
    - University of Cincinnati
    - Kontakt:
      
      Stephanie Byrd
    - Ledende efterforsker:
      
      Srinivas Rajsheker, MD
    - Underforsker:
      
      Wai Tam, MD
  - Columbus, Ohio, Forenede Stater, 43213
    - Rekruttering
    - Mount Carmel Columbus Cardiology Consultants
    - Ledende efterforsker:
      
      Lee Gemma, MD
    - Kontakt:
      
      Elissa VanKirk
      
      Telefonnummer: 614-546-4327
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Rekruttering
    - Oklahoma Heart Hospital
    - Ledende efterforsker:
      
      Charles Te, MD
    - Kontakt:
      
      Terri Knight
    - Underforsker:
      
      Subha Varahan, MD
- Pennsylvania
  - Lancaster, Pennsylvania, Forenede Stater, 17602
    - Rekruttering
    - Lancaster General Hospital
    - Ledende efterforsker:
      
      Sandeep Bansal, MD
    - Kontakt:
      
      Andrew Hershey
    - Underforsker:
      
      Matthew Bernabei, MD
    - Underforsker:
      
      Jeffrey Arkles, MD
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Rekruttering
    - University of Pennsylvania, Penn Presbyterian Medical Center
    - Ledende efterforsker:
      
      Benjamin D'Souza, MD
    - Kontakt:
      
      Katie Shoemaker
  - Pittsburgh, Pennsylvania, Forenede Stater, 15222
    - Rekruttering
    - Allegheny Health Network
    - Ledende efterforsker:
      
      Joshua Silverstein, MD
    - Kontakt:
      
      Caitlin Phalunas
    - Underforsker:
      
      Amit Thosani, MD
    - Underforsker:
      
      Emerson Liu, MD
    - Underforsker:
      
      George Shaw, MD
    - Underforsker:
      
      William Belding, MD
    - Underforsker:
      
      Mati Friehling, MD
    - Underforsker:
      
      Tharian Cherian, MD
  - York, Pennsylvania, Forenede Stater, 17403
    - Rekruttering
    - WellSpan Health
    - Kontakt:
      
      Elayne Grim
    - Ledende efterforsker:
      
      Matthew Singleton, MD
    - Underforsker:
      
      Edmond Obeng-Gyimah, MD
    - Underforsker:
      
      Jefferson Lee, MD
- South Carolina
  - Greenville, South Carolina, Forenede Stater, 29607
    - Rekruttering
    - Upstate Cardiology
    - Ledende efterforsker:
      
      Matthew Sellers, MD
    - Kontakt:
      
      Ericka Calhoun
  - Rock Hill, South Carolina, Forenede Stater, 29732
    - Afsluttet
    - Carolina Cardiology Associates and OnSite Clinical Solutions
- Tennessee
  - Jackson, Tennessee, Forenede Stater, 38305
    - Rekruttering
    - Jackson-Madison County General Hospital
    - Kontakt:
      
      Cindi Thompson
      
      E-mail: cindi.thompson@wth.org
    - Ledende efterforsker:
      
      Simon Okewole, MD
- Texas
  - Austin, Texas, Forenede Stater, 78705
    - Rekruttering
    - Texas Cardiac Arrhythmia Foundation
    - Kontakt:
      
      Deb Cardinal
      
      E-mail: dcardinal@austinheartbeat.com
    - Ledende efterforsker:
      
      J. David Burkhardt, MD
  - Dallas, Texas, Forenede Stater, 75204
    - Rekruttering
    - Baylor Scott & White Research Institute
    - Ledende efterforsker:
      
      Aleem Mughal, MD
    - Kontakt:
      
      Kristina Perez
  - Dallas, Texas, Forenede Stater, 75320
    - Rekruttering
    - Medical City Dallas Hospital
    - Kontakt:
      
      Corryn Weatherred
    - Ledende efterforsker:
      
      Javier Sanchez, MD
    - Underforsker:
      
      Sunil Reddy, MD
    - Underforsker:
      
      Kamala Tamirisa, MD
    - Underforsker:
      
      Jodie Hurwitz, MD
    - Underforsker:
      
      Rajeev Joshi, MD
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84124
    - Rekruttering
    - St. Mark's Hospital
    - Kontakt:
      
      Sherry Fisher
    - Ledende efterforsker:
      
      Nischala Nannapaneni, MD
- Virginia
  - Lynchburg, Virginia, Forenede Stater, 24501
    - Rekruttering
    - Centra Health, Inc. dba Stroobants Cardiovascular Center
    - Ledende efterforsker:
      
      Matthew Sackett, MD
    - Underforsker:
      
      Richard Kuk, MD
    - Underforsker:
      
      Jose Silva, MD
    - Underforsker:
      
      Julia McHugh, MD
    - Underforsker:
      
      Chinmaya Mareddy, MD
    - Kontakt:
      
      Cindy Baumann
  - Midlothian, Virginia, Forenede Stater, 23114
    - Rekruttering
    - Bon Secours St. Marys
    - Kontakt:
      
      Kelly Patterson
    - Ledende efterforsker:
      
      An H Bui, MD
  - Richmond, Virginia, Forenede Stater, 23261
    - Rekruttering
    - CJW Medical Center
    - Kontakt:
      
      Ariana Dickens
    - Ledende efterforsker:
      
      Michael Rehorn, MD
  - Winchester, Virginia, Forenede Stater, 22601
    - Rekruttering
    - Valley Health
    - Kontakt:
      
      Janie Simpson
    - Ledende efterforsker:
      
      Emmanuel Ekanem, MD
- Washington
  - Seattle, Washington, Forenede Stater, 98195
    - Rekruttering
    - University of Washington-Seattle
    - Ledende efterforsker:
      
      Babak Nazer, MD
    - Kontakt:
      
      Shiva Tabaghi, MD
      
      E-mail: shiva102@uw.edu
  - Tacoma, Washington, Forenede Stater, 98405
    - Rekruttering
    - MultiCare Institute for Research & Innovation
    - Ledende efterforsker:
      
      Tariq Salam, MD
    - Underforsker:
      
      Jeffrey Ho, MD
    - Kontakt:
      
      Kari Davidson
- Wisconsin
  - Janesville, Wisconsin, Forenede Stater, 53548
    - Rekruttering
    - MercyHealth
    - Kontakt:
      
      Kaitlyn Phetteplace, MSN
    - Ledende efterforsker:
      
      Imdad Ahmed, MD
  - Madison, Wisconsin, Forenede Stater, 53792
    - Rekruttering
    - University of Wisconsin
    - Kontakt:
      
      Torrey Tiedman
    - Ledende efterforsker:
      
      Blake Fleeman, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation in the REAL AF Cohort and adults age 18 years or older with documented ventricular arrhythmia appropriate for catheter ablation in the CORE VA Cohort.

Beskrivelse

REAL AF Cohort

Inclusion Criteria:

Symptomatic PAF (AF episode terminate spontaneously within 7 days) or PsAF (AF sustained beyond 7 days, but less than 365 days) subjects who, in the opinion of the investigator, are candidates for catheter ablation.
>18 years of age.
Will be treated with Biosense Webster Inc. ablation technologies
All AF ablations performed with BWI catheters are included. This includes repeat ablations where the index procedure was performed with a non-BWI catheter.
Able and willing to participate in baseline and follow up evaluations
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)
In the opinion of the investigator, any known contraindication to an ablation procedure

CORE VA Cohort

Inclusion Criteria:

Documented ventricular arrhythmia appropriate for catheter ablation.
>18 years of age.
Will be treated with Biosense Webster Inc. ablation technologies
Able and willing to participate in baseline and follow up evaluations
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.
In the opinion of the investigator, any known contraindication to an ablation procedure.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: COHORT
Tidsperspektiver: OTHER

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte	Intervention / Behandling
REAL AF 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.	Enhed: Catheter ablation Ablation using Biosense Webster, Inc. (BWI) CARTO™ technologies (e.g., THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available.
CORE VA Subjects with documented ventricular arrhythmia appropriate for catheter ablation, greater than 18 years of age, will be treated with Biosense Webster Inc. ablation technologies, and are willing and able to participate in baseline and follow up evaluations.	Enhed: Catheter ablation Ablation using Biosense Webster, Inc. (BWI) CARTO™ technologies (e.g., THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Effectiveness at 90 days Tidsramme: 90 days	Freedom from arrhythmia recurrence at 90 days post procedure.	90 days
Effectiveness at 12 months Tidsramme: 12 months	Freedom from subject reported arrhythmia recurrence through 12 months post procedure.	12 months
Long-term Safety Tidsramme: 30 days post ablation	Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related	30 days post ablation

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Arrhythmia recurrence Tidsramme: 12 months	Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE	12 months
Post-procedure arrhythmia treatments Tidsramme: 12 months	Treatments for arrhythmia post-procedure	12 months
Arrhythmia related symptoms Tidsramme: 12 months	Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no)	12 months
AAD Usage Tidsramme: 12 months	Antiarrhythmic drug use (and type) post procedure and 12 months	12 months
OAC usage Tidsramme: 12 months	Oral anticoagulant use at 12 months and drug type	12 months
CHA2DS2VASC Tidsramme: 12 months	An estimation of stroke risk for patients with Atrial Fibrillation. Composite score of: Age (<65= 0; 65-74=1; >75=2) + Sex (Female=1; Male=0) + Congestive Heart Failure (Yes =1; No=0) + Hypertension (Yes= 1; No= 0) + Stroke, Transient Ischemic Attack (TIA) or thromboembolism (Yes=2; No=0) + Vascular Disease (Yes=1; No=0) + Diabetes (Yes=1; No=0). Scores range from 0 to 9, with higher scores indicating greater risk for stroke.	12 months
Patient reported outcome Tidsramme: 12 months	How do you feel now compared to pre-ablation?	12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Samarbejdspartnere

Biosense Webster, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2018

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

26. august 2019

Først indsendt, der opfyldte QC-kriterier

10. september 2019

Først opslået (Faktiske)

12. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CTP-1
Ventricular Arrhythmia (Registry Identifier: CORE VA Registry)
Atrial Fibrillation (Registry Identifier: REAL AF)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Erfaring fra den virkelige verden med kateterablation til behandling af paroxysmal og vedvarende atrieflimren (REAL Registry)

Erfaring fra den virkelige verden med kateterablation til behandling af symptomatisk paroxysmal og vedvarende atrieflimren ved brug af nye Contact Force-teknologier: REAL AF Registry

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Anslået)

Kontakter og lokationer

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Prøveudtagningsmetode

Studiebefolkning

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.