- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04088071
발작성 및 지속성 심방 세동 치료를 위한 카테터 절제술의 실제 경험 (REAL Registry)
새로운 접촉력 기술을 사용한 증후성 발작 및 지속성 심방 세동 치료를 위한 카테터 절제술의 실제 경험: 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jose Osorio, MD
- 이메일: josorio@hrcrs.com
연구 연락처 백업
- 이름: April Bond, MS
- 전화번호: 1-901-828-5707
- 이메일: abond@hrcrs.com
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35233
- 모병
- University of Alabama at Birmingham
-
수석 연구원:
- William Maddox, MD
-
연락하다:
- Michelle Osoinak
-
Birmingham, Alabama, 미국, 35243
- 모병
- Grandview Medical Center
-
부수사관:
- Gustavo Morales, MD
-
수석 연구원:
- Anil Rajendra, MD
-
연락하다:
- Susan Thorington
-
Mobile, Alabama, 미국, 36695
- 모병
- Cardiology Associates of Mobile
-
수석 연구원:
- Matthew Quin, MD
-
연락하다:
- Lynn Ward
-
-
Arizona
-
Chandler, Arizona, 미국, 85224
- 모병
- Valley Heart Rhythm Specialists
-
수석 연구원:
- Huy Phan, MD
-
연락하다:
- Gianani Cabrera
-
Tucson, Arizona, 미국, 85741
- 모병
- Pima Heart and Vascular
-
연락하다:
- Monica Varela
- 전화번호: 5209756400
- 이메일: monica.varela@usheartandvascular.com
-
수석 연구원:
- Jitender Munjal, MD
-
-
Arkansas
-
Jonesboro, Arkansas, 미국, 72401
- 모병
- Arrhythmia Research Group
-
수석 연구원:
- Devi Nair, MD
-
연락하다:
- Kayla Rubino
-
-
California
-
Los Angeles, California, 미국, 90033
- 모병
- Keck School of Medicine
-
연락하다:
- Silvia Perez
-
수석 연구원:
- Ivan Ho, MD
-
부수사관:
- Junaid Zaman, PhD, MD
-
부수사관:
- Andrew Zadeh, MD
-
부수사관:
- Steven Leung, MD
-
Santa Barbara, California, 미국, 93105
- 종료됨
- Santa Barbara Cottage Hospital
-
Ventura, California, 미국, 93303
- 모병
- Community Memorial Hospital
-
연락하다:
- Jennifer Freeland
-
수석 연구원:
- Jonathan Dukes, MD
-
Walnut Creek, California, 미국, 94598
- 완전한
- University HealthCare Alliance
-
-
Colorado
-
Aurora, Colorado, 미국, 80012
- 모병
- The Medical Center of Aurora
-
연락하다:
- Chris Dutka
-
수석 연구원:
- Christopher Porterfield, MD
-
Golden, Colorado, 미국, 80401
- 모병
- Colorado Heart and Vascular
-
연락하다:
- David Bailey
-
Littleton, Colorado, 미국, 80120
- 모병
- South Denver Cardiology
-
연락하다:
- Kathy Siegel
-
수석 연구원:
- Daniel Alyesh, MD
-
-
Florida
-
Jacksonville, Florida, 미국, 32204
- 모병
- Ascension St. Vincent's
-
수석 연구원:
- Saumil Oza, MD
-
연락하다:
- Jasmine Vestal
-
부수사관:
- Anthony Magnano, MD
-
Miami, Florida, 미국, 33133
- 모병
- HCA Florida Mercy Hospital
-
수석 연구원:
- Jose Osorio, MD
-
연락하다:
- Isabel Vital
-
Naples, Florida, 미국, 34101
- 모병
- Naples Community Hospital
-
연락하다:
- Anessa B Diers
-
수석 연구원:
- Dinesh Sharma, MD
-
Pensacola, Florida, 미국, 32504
- 모병
- Ascension Sacred Heart
-
연락하다:
- Ashley Corlies
-
수석 연구원:
- Asim Ahmed, DO
-
Sarasota, Florida, 미국, 34239
- 모병
- Sarasota Memorial Hospital
-
연락하다:
- Colleen Linder
-
수석 연구원:
- Antonio Moretta, MD
-
Tampa, Florida, 미국, 33606
- 모병
- Baycare Health Tampa
-
연락하다:
- Christian Kelbaugh
- 전화번호: 8132548055
- 이메일: christian.kelbaugh@baycare.org
-
수석 연구원:
- Shalin Shah, MD
-
Winterhaven, Florida, 미국, 33881
- 모병
- Baycare Health System
-
수석 연구원:
- Rodrigo Bolanos, MD
-
연락하다:
- Lynda Argenzio
-
-
Georgia
-
Atlanta, Georgia, 미국, 30309
- 모병
- Piedmont Healthcare
-
수석 연구원:
- Sandeep Goyal, MD
-
부수사관:
- Michael Hoosien, MD
-
부수사관:
- Ashish Bhimani, MD
-
부수사관:
- Kavita Krishnasamy, MD
-
연락하다:
- Mariam Nuhu
-
Savannah, Georgia, 미국, 31404
- 모병
- Memorial Health University Medical Center
-
연락하다:
- Alta Castellino, BSN
-
연락하다:
- Ritzie Anne Trinidad, MBA
-
수석 연구원:
- David Newton, MD
-
부수사관:
- Todd Senn, MD
-
-
Hawaii
-
Honolulu, Hawaii, 미국, 97813
- 완전한
- The Queen's Medical Center
-
-
Illinois
-
Evanston, Illinois, 미국, 60201
- 모병
- Northshore University Health System
-
수석 연구원:
- Mark Metzl, MD
-
부수사관:
- Jose Nazari, MD
-
부수사관:
- Alex Ro, MD
-
연락하다:
- Marisa Durante
-
부수사관:
- Jeremiah Wasserlauf, MD
-
Naperville, Illinois, 미국, 60540
- 모병
- Midwest Cardiovascular Institute
-
연락하다:
- Sherri McCoy
- 전화번호: 630-600-0700
- 이메일: sherri.mccoy@cardio.com
-
수석 연구원:
- Kousik Krishnan, MD
-
Springfield, Illinois, 미국, 62704
- 모병
- Prairie Education and Research
-
부수사관:
- Suresh Kulandhaisamy, MD
-
연락하다:
- Magen Kaler
-
수석 연구원:
- Paban Saha, MD
-
부수사관:
- Michael Hushion, MD
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46260
- 모병
- Ascension St. Vincent's Hospital
-
수석 연구원:
- Parin Patel, MD
-
연락하다:
- Anne Renick
-
-
Iowa
-
Iowa City, Iowa, 미국, 52242
- 모병
- University of Iowa
-
수석 연구원:
- Paari Dominic, MD
-
연락하다:
- Trisha Elliot
-
-
Kentucky
-
Louisville, Kentucky, 미국, 40205
- 모병
- Norton Heart Specialists
-
수석 연구원:
- Kent Morris, MD
-
부수사관:
- Kevin Thomas, MD
-
부수사관:
- Hassan Khan, MD
-
연락하다:
- Tina Abell, RN, BSN
-
Saint Matthews, Kentucky, 미국, 40207
- 모병
- Baptist Health Louisville
-
연락하다:
- Karin Cryan
-
수석 연구원:
- Kevin Parrott, MD
-
-
Maine
-
Portland, Maine, 미국, 04102
- 모병
- Maine Medical Center
-
연락하다:
- Joanne Burgess
-
수석 연구원:
- Jordan Leyton-Mange, MD
-
부수사관:
- Andrew Corsello, MD
-
부수사관:
- Henry Sesselberg, MD
-
부수사관:
- Edwin Sze, MD
-
부수사관:
- Kunal Tandon, MD
-
-
Maryland
-
Lanham, Maryland, 미국, 20706
- 모병
- Capitol CArdiology
-
연락하다:
- Iluyomade Adeusi
-
수석 연구원:
- Mohit Rastogi, MD
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- 모병
- Brigham and Women's Hospital
-
부수사관:
- Jorge Romero, MD
-
수석 연구원:
- Paul Zei, MD, PhD
-
부수사관:
- Nathaniel Steiger, MD
-
부수사관:
- Thomas Tadros, MD
-
연락하다:
- Deborah Manuelian
- 전화번호: 617-732-5087
-
-
Michigan
-
Detroit, Michigan, 미국, 48202
- 모병
- Henry Ford Health
-
연락하다:
- Briita Wanhala
-
수석 연구원:
- Arfaat Khan, MD
-
Lansing, Michigan, 미국, 48910
- 모집하지 않고 적극적으로
- McLaren Greater Lansing
-
Lansing, Michigan, 미국, 48912
- 모병
- Sparrow Clinical Research
-
연락하다:
- Jennifer Boak
-
수석 연구원:
- Ali Sheikh, MD
-
Royal Oak, Michigan, 미국, 48073
- 모병
- William Beaumont Hospital
-
수석 연구원:
- Brian Williamson, MD
-
연락하다:
- Greg Schlosser
-
Ypsilanti, Michigan, 미국, 48197
- 모병
- Michigan Heart
-
부수사관:
- Andrew Hughey, MD
-
연락하다:
- Elizabeth Goetz
-
부수사관:
- Mohammed-Ali Jazayeri, MD
-
수석 연구원:
- Mohammad-Ali Jazayeri, MD
-
-
Mississippi
-
Jackson, Mississippi, 미국, 39202
- 모병
- Mississippi Baptist Medical Center
-
연락하다:
- Sherrina N. Dixon
-
연락하다:
- Greta Beatty
-
수석 연구원:
- Adam Berman, MD
-
-
Missouri
-
Columbia, Missouri, 미국, 65212
- 모병
- University of Missouri
-
연락하다:
- Charles Donigian
-
수석 연구원:
- Sandeep Gautam, MD
-
부수사관:
- Rahul Jain, MD
-
Springfield, Missouri, 미국, 65807
- 모병
- CoxHealth
-
연락하다:
- Sam Atkinson
-
수석 연구원:
- John Garner, MD
-
부수사관:
- Scott Ferreira, MD
-
-
New Jersey
-
Haddon Heights, New Jersey, 미국, 08035
- 모병
- Cardiovascular Associates of the Delaware Valley
-
수석 연구원:
- George Mark, MD
-
부수사관:
- Steven Levi, MD
-
연락하다:
- Kaitlyn Downey
-
부수사관:
- John Costello, DO
-
-
New Mexico
-
Albuquerque, New Mexico, 미국, 87102
- 모병
- Lovelace Health System
-
부수사관:
- Michael Bestawros, MD
-
수석 연구원:
- Sean Mazer, MD
-
부수사관:
- Michael Hoskins, MD
-
부수사관:
- Yaw Adej-Poku, MD
-
부수사관:
- Sandeep Nair, MD
-
연락하다:
- Alexandra Ortiz
-
-
New York
-
New York, New York, 미국, 10032
- 모병
- Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)
-
연락하다:
- Kate Dalton
- 전화번호: 347-514-3666
- 이메일: keb2114@cumc.columbia.edu
-
수석 연구원:
- Angelo Biviano, MD
-
Poughkeepsie, New York, 미국, 12601
- 모병
- Nuvance Health
-
연락하다:
- Olatunde Olaniyi
-
수석 연구원:
- David Steckman, MD
-
Syracuse, New York, 미국, 13210
- 모병
- Crouse Health System and Crouse Medical Practice
-
연락하다:
- Jennifer Peterson
- 전화번호: 3154707111
- 이메일: jenniferapeterson@crousemed.com
-
수석 연구원:
- Nikhil Joshi, MD
-
-
North Carolina
-
Asheville, North Carolina, 미국, 28801
- 모병
- Mission Hospital
-
연락하다:
- Alex Boyd
-
수석 연구원:
- Jason Lappe, MD
-
부수사관:
- Michael Manogue, MD
-
부수사관:
- John Brandt, MD
-
부수사관:
- Zachary Hale, MD
-
Winston-Salem, North Carolina, 미국, 27103
- 모병
- Novant Health Forsyth Medical Center
-
연락하다:
- Patricia Reece
-
수석 연구원:
- Nicholas Costa, MD
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45219
- 모병
- The Christ Hospital
-
수석 연구원:
- Alexandru Costea, MD
-
연락하다:
- Anne Voorhorst
-
Cincinnati, Ohio, 미국, 45202
- 모병
- University of Cincinnati
-
연락하다:
- Stephanie Byrd
-
수석 연구원:
- Srinivas Rajsheker, MD
-
부수사관:
- Wai Tam, MD
-
Columbus, Ohio, 미국, 43213
- 모병
- Mount Carmel Columbus Cardiology Consultants
-
수석 연구원:
- Lee Gemma, MD
-
연락하다:
- Elissa VanKirk
- 전화번호: 614-546-4327
-
-
Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73120
- 모병
- Oklahoma Heart Hospital
-
수석 연구원:
- Charles Te, MD
-
연락하다:
- Terri Knight
-
부수사관:
- Subha Varahan, MD
-
-
Pennsylvania
-
Lancaster, Pennsylvania, 미국, 17602
- 모병
- Lancaster General Hospital
-
수석 연구원:
- Sandeep Bansal, MD
-
연락하다:
- Andrew Hershey
-
부수사관:
- Matthew Bernabei, MD
-
부수사관:
- Jeffrey Arkles, MD
-
Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania, Penn Presbyterian Medical Center
-
수석 연구원:
- Benjamin D'Souza, MD
-
연락하다:
- Katie Shoemaker
-
Pittsburgh, Pennsylvania, 미국, 15222
- 모병
- Allegheny Health Network
-
수석 연구원:
- Joshua Silverstein, MD
-
연락하다:
- Caitlin Phalunas
-
부수사관:
- Amit Thosani, MD
-
부수사관:
- Emerson Liu, MD
-
부수사관:
- George Shaw, MD
-
부수사관:
- William Belding, MD
-
부수사관:
- Mati Friehling, MD
-
부수사관:
- Tharian Cherian, MD
-
York, Pennsylvania, 미국, 17403
- 모병
- WellSpan Health
-
연락하다:
- Elayne Grim
-
수석 연구원:
- Matthew Singleton, MD
-
부수사관:
- Edmond Obeng-Gyimah, MD
-
부수사관:
- Jefferson Lee, MD
-
-
South Carolina
-
Greenville, South Carolina, 미국, 29607
- 모병
- Upstate Cardiology
-
수석 연구원:
- Matthew Sellers, MD
-
연락하다:
- Ericka Calhoun
-
Rock Hill, South Carolina, 미국, 29732
- 종료됨
- Carolina Cardiology Associates and OnSite Clinical Solutions
-
-
Tennessee
-
Jackson, Tennessee, 미국, 38305
- 모병
- Jackson-Madison County General Hospital
-
연락하다:
- Cindi Thompson
- 이메일: cindi.thompson@wth.org
-
수석 연구원:
- Simon Okewole, MD
-
-
Texas
-
Austin, Texas, 미국, 78705
- 모병
- Texas Cardiac Arrhythmia Foundation
-
연락하다:
- Deb Cardinal
- 이메일: dcardinal@austinheartbeat.com
-
수석 연구원:
- J. David Burkhardt, MD
-
Dallas, Texas, 미국, 75204
- 모병
- Baylor Scott & White Research Institute
-
수석 연구원:
- Aleem Mughal, MD
-
연락하다:
- Kristina Perez
-
Dallas, Texas, 미국, 75320
- 모병
- Medical City Dallas Hospital
-
연락하다:
- Corryn Weatherred
-
수석 연구원:
- Javier Sanchez, MD
-
부수사관:
- Sunil Reddy, MD
-
부수사관:
- Kamala Tamirisa, MD
-
부수사관:
- Jodie Hurwitz, MD
-
부수사관:
- Rajeev Joshi, MD
-
-
Utah
-
Salt Lake City, Utah, 미국, 84124
- 모병
- St. Mark's Hospital
-
연락하다:
- Sherry Fisher
-
수석 연구원:
- Nischala Nannapaneni, MD
-
-
Virginia
-
Lynchburg, Virginia, 미국, 24501
- 모병
- Centra Health, Inc. dba Stroobants Cardiovascular Center
-
수석 연구원:
- Matthew Sackett, MD
-
부수사관:
- Richard Kuk, MD
-
부수사관:
- Jose Silva, MD
-
부수사관:
- Julia McHugh, MD
-
부수사관:
- Chinmaya Mareddy, MD
-
연락하다:
- Cindy Baumann
-
Midlothian, Virginia, 미국, 23114
- 모병
- Bon Secours St. Marys
-
연락하다:
- Kelly Patterson
-
수석 연구원:
- An H Bui, MD
-
Richmond, Virginia, 미국, 23261
- 모병
- CJW Medical Center
-
연락하다:
- Ariana Dickens
-
수석 연구원:
- Michael Rehorn, MD
-
Winchester, Virginia, 미국, 22601
- 모병
- Valley Health
-
연락하다:
- Janie Simpson
-
수석 연구원:
- Emmanuel Ekanem, MD
-
-
Washington
-
Seattle, Washington, 미국, 98195
- 모병
- University of Washington-Seattle
-
수석 연구원:
- Babak Nazer, MD
-
연락하다:
- Shiva Tabaghi, MD
- 이메일: shiva102@uw.edu
-
Tacoma, Washington, 미국, 98405
- 모병
- MultiCare Institute for Research & Innovation
-
수석 연구원:
- Tariq Salam, MD
-
부수사관:
- Jeffrey Ho, MD
-
연락하다:
- Kari Davidson
-
-
Wisconsin
-
Janesville, Wisconsin, 미국, 53548
- 모병
- MercyHealth
-
연락하다:
- Kaitlyn Phetteplace, MSN
-
수석 연구원:
- Imdad Ahmed, MD
-
Madison, Wisconsin, 미국, 53792
- 모병
- University of Wisconsin
-
연락하다:
- Torrey Tiedman
-
수석 연구원:
- Blake Fleeman, MD
-
-
-
-
Alberta
-
Edmonton, Alberta, 캐나다, T6G2B7
- 모병
- Alberta Health
-
연락하다:
- Wei Chen
-
수석 연구원:
- Kenneth Quadros, MD
-
-
Ontario
-
Kitchener, Ontario, 캐나다, N2M 5N6
- 모병
- Waterloo Wellington Cardiovascular Research Institute
-
수석 연구원:
- Umjeet Jolly, MD
-
연락하다:
- Mary Radyk
- 이메일: mradyk@wwcri.ca
-
Newmarket, Ontario, 캐나다, L3Y2P6
- 모병
- Southlake Regional Health Centre
-
수석 연구원:
- Yaariv Khaykin, MD
-
연락하다:
- Lynn Nyman
-
-
Quebec
-
Montreal, Quebec, 캐나다, H1T 1C8
- 모병
- Montreal Heart Institute
-
연락하다:
- Caroline Girard
- 이메일: caroline.girard@icm-mhi.org
-
수석 연구원:
- Martin Aguilar, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Effectiveness at 90 days
기간: 90 days
|
Freedom from arrhythmia recurrence at 90 days post procedure. |
90 days
|
|
Effectiveness at 12 months
기간: 12 months
|
Freedom from subject reported arrhythmia recurrence through 12 months post procedure. |
12 months
|
|
Long-term Safety
기간: 30 days post ablation
|
Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related |
30 days post ablation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Arrhythmia recurrence
기간: 12 months
|
Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE |
12 months
|
|
Post-procedure arrhythmia treatments
기간: 12 months
|
Treatments for arrhythmia post-procedure |
12 months
|
|
Arrhythmia related symptoms
기간: 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
기간: 12 months
|
Antiarrhythmic drug use (and type) post procedure and 12 months |
12 months
|
|
OAC usage
기간: 12 months
|
Oral anticoagulant use at 12 months and drug type |
12 months
|
|
CHA2DS2VASC
기간: 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
기간: 12 months
|
How do you feel now compared to pre-ablation? |
12 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Zhang Z, Hincapie D, Thorne C, Varley A, Justice L, Osorio J, Moretta A, Silverstein J, Rajendra A, Morales G, Goyal S, Khaykin Y, Sadek M, D'Souza B, Ahmed I, Jazayeri MA, Varahan S, Sackett M, McHugh J, Costea A, Black AL, Yao Y, Sauer WH, Zei PC; REAL-AF Investigators. Real-world data of sex differences in atrial fibrillation catheter ablation: Insights from a prospective multicenter registry. Heart Rhythm O2. 2026 Apr 13;7(7):1259-1273. doi: 10.1016/j.hroo.2026.04.005. eCollection 2026 Jul.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTP-1
- Ventricular Arrhythmia (레지스트리 식별자: CORE VA Registry)
- Atrial Fibrillation (레지스트리 식별자: REAL AF)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .