导管消融治疗阵发性和持续性心房颤动的真实经验 (REAL Registry)
使用新型接触力技术进行导管消融治疗有症状的阵发性和持续性心房颤动的真实经验: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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Jose Osorio, MD
- 邮箱:josorio@hrcrs.com
研究联系人备份
- 姓名:April Bond, MS
- 电话号码:1-901-828-5707
- 邮箱:abond@hrcrs.com
学习地点
-
-
Alberta
-
Edmonton、Alberta、加拿大、T6G2B7
- 招聘中
- Alberta Health
-
接触:
- Wei Chen
-
首席研究员:
- Kenneth Quadros, MD
-
-
Ontario
-
Kitchener、Ontario、加拿大、N2M 5N6
- 招聘中
- Waterloo Wellington Cardiovascular Research Institute
-
首席研究员:
- Umjeet Jolly, MD
-
接触:
- Mary Radyk
- 邮箱:mradyk@wwcri.ca
-
Newmarket、Ontario、加拿大、L3Y2P6
- 招聘中
- Southlake Regional Health Centre
-
首席研究员:
- Yaariv Khaykin, MD
-
接触:
- Lynn Nyman
-
-
Quebec
-
Montreal、Quebec、加拿大、H1T 1C8
- 招聘中
- Montreal Heart Institute
-
接触:
- Caroline Girard
- 邮箱:caroline.girard@icm-mhi.org
-
首席研究员:
- Martin Aguilar, MD
-
-
-
-
Alabama
-
Birmingham、Alabama、美国、35233
- 招聘中
- University of Alabama at Birmingham
-
首席研究员:
- William Maddox, MD
-
接触:
- Michelle Osoinak
-
Birmingham、Alabama、美国、35243
- 招聘中
- Grandview Medical Center
-
副研究员:
- Gustavo Morales, MD
-
首席研究员:
- Anil Rajendra, MD
-
接触:
- Susan Thorington
-
Mobile、Alabama、美国、36695
- 招聘中
- Cardiology Associates of Mobile
-
首席研究员:
- Matthew Quin, MD
-
接触:
- Lynn Ward
-
-
Arizona
-
Chandler、Arizona、美国、85224
- 招聘中
- Valley Heart Rhythm Specialists
-
首席研究员:
- Huy Phan, MD
-
接触:
- Gianani Cabrera
-
Tucson、Arizona、美国、85741
- 招聘中
- Pima Heart and Vascular
-
接触:
- Monica Varela
- 电话号码:5209756400
- 邮箱:monica.varela@usheartandvascular.com
-
首席研究员:
- Jitender Munjal, MD
-
-
Arkansas
-
Jonesboro、Arkansas、美国、72401
- 招聘中
- Arrhythmia Research Group
-
首席研究员:
- Devi Nair, MD
-
接触:
- Kayla Rubino
-
-
California
-
Los Angeles、California、美国、90033
- 招聘中
- Keck School of Medicine
-
接触:
- Silvia Perez
-
首席研究员:
- Ivan Ho, MD
-
副研究员:
- Junaid Zaman, PhD, MD
-
副研究员:
- Andrew Zadeh, MD
-
副研究员:
- Steven Leung, MD
-
Santa Barbara、California、美国、93105
- 终止
- Santa Barbara Cottage Hospital
-
Ventura、California、美国、93303
- 招聘中
- Community Memorial Hospital
-
接触:
- Jennifer Freeland
-
首席研究员:
- Jonathan Dukes, MD
-
Walnut Creek、California、美国、94598
- 完全的
- University HealthCare Alliance
-
-
Colorado
-
Aurora、Colorado、美国、80012
- 招聘中
- The Medical Center of Aurora
-
接触:
- Chris Dutka
-
首席研究员:
- Christopher Porterfield, MD
-
Golden、Colorado、美国、80401
- 招聘中
- Colorado Heart and Vascular
-
接触:
- David Bailey
-
Littleton、Colorado、美国、80120
- 招聘中
- South Denver Cardiology
-
接触:
- Kathy Siegel
-
首席研究员:
- Daniel Alyesh, MD
-
-
Florida
-
Jacksonville、Florida、美国、32204
- 招聘中
- Ascension St. Vincent's
-
首席研究员:
- Saumil Oza, MD
-
接触:
- Jasmine Vestal
-
副研究员:
- Anthony Magnano, MD
-
Miami、Florida、美国、33133
- 招聘中
- HCA Florida Mercy Hospital
-
首席研究员:
- Jose Osorio, MD
-
接触:
- Isabel Vital
-
Naples、Florida、美国、34101
- 招聘中
- Naples Community Hospital
-
接触:
- Anessa B Diers
-
首席研究员:
- Dinesh Sharma, MD
-
Pensacola、Florida、美国、32504
- 招聘中
- Ascension Sacred Heart
-
接触:
- Ashley Corlies
-
首席研究员:
- Asim Ahmed, DO
-
Sarasota、Florida、美国、34239
- 招聘中
- Sarasota Memorial Hospital
-
接触:
- Colleen Linder
-
首席研究员:
- Antonio Moretta, MD
-
Tampa、Florida、美国、33606
- 招聘中
- Baycare Health Tampa
-
接触:
- Christian Kelbaugh
- 电话号码:8132548055
- 邮箱:christian.kelbaugh@baycare.org
-
首席研究员:
- Shalin Shah, MD
-
Winterhaven、Florida、美国、33881
- 招聘中
- Baycare Health System
-
首席研究员:
- Rodrigo Bolanos, MD
-
接触:
- Lynda Argenzio
-
-
Georgia
-
Atlanta、Georgia、美国、30309
- 招聘中
- Piedmont Healthcare
-
首席研究员:
- Sandeep Goyal, MD
-
副研究员:
- Michael Hoosien, MD
-
副研究员:
- Ashish Bhimani, MD
-
副研究员:
- Kavita Krishnasamy, MD
-
接触:
- Mariam Nuhu
-
Savannah、Georgia、美国、31404
- 招聘中
- Memorial Health University Medical Center
-
接触:
- Alta Castellino, BSN
-
接触:
- Ritzie Anne Trinidad, MBA
-
首席研究员:
- David Newton, MD
-
副研究员:
- Todd Senn, MD
-
-
Hawaii
-
Honolulu、Hawaii、美国、97813
- 完全的
- The Queen's Medical Center
-
-
Illinois
-
Evanston、Illinois、美国、60201
- 招聘中
- Northshore University Health System
-
首席研究员:
- Mark Metzl, MD
-
副研究员:
- Jose Nazari, MD
-
副研究员:
- Alex Ro, MD
-
接触:
- Marisa Durante
-
副研究员:
- Jeremiah Wasserlauf, MD
-
Naperville、Illinois、美国、60540
- 招聘中
- Midwest Cardiovascular Institute
-
接触:
- Sherri McCoy
- 电话号码:630-600-0700
- 邮箱:sherri.mccoy@cardio.com
-
首席研究员:
- Kousik Krishnan, MD
-
Springfield、Illinois、美国、62704
- 招聘中
- Prairie Education and Research
-
副研究员:
- Suresh Kulandhaisamy, MD
-
接触:
- Magen Kaler
-
首席研究员:
- Paban Saha, MD
-
副研究员:
- Michael Hushion, MD
-
-
Indiana
-
Indianapolis、Indiana、美国、46260
- 招聘中
- Ascension St. Vincent's Hospital
-
首席研究员:
- Parin Patel, MD
-
接触:
- Anne Renick
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- 招聘中
- University of Iowa
-
首席研究员:
- Paari Dominic, MD
-
接触:
- Trisha Elliot
-
-
Kentucky
-
Louisville、Kentucky、美国、40205
- 招聘中
- Norton Heart Specialists
-
首席研究员:
- Kent Morris, MD
-
副研究员:
- Kevin Thomas, MD
-
副研究员:
- Hassan Khan, MD
-
接触:
- Tina Abell, RN, BSN
-
Saint Matthews、Kentucky、美国、40207
- 招聘中
- Baptist Health Louisville
-
接触:
- Karin Cryan
-
首席研究员:
- Kevin Parrott, MD
-
-
Maine
-
Portland、Maine、美国、04102
- 招聘中
- Maine Medical Center
-
接触:
- Joanne Burgess
-
首席研究员:
- Jordan Leyton-Mange, MD
-
副研究员:
- Andrew Corsello, MD
-
副研究员:
- Henry Sesselberg, MD
-
副研究员:
- Edwin Sze, MD
-
副研究员:
- Kunal Tandon, MD
-
-
Maryland
-
Lanham、Maryland、美国、20706
- 招聘中
- Capitol CArdiology
-
接触:
- Iluyomade Adeusi
-
首席研究员:
- Mohit Rastogi, MD
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- 招聘中
- Brigham and Women's Hospital
-
副研究员:
- Jorge Romero, MD
-
首席研究员:
- Paul Zei, MD, PhD
-
副研究员:
- Nathaniel Steiger, MD
-
副研究员:
- Thomas Tadros, MD
-
接触:
- Deborah Manuelian
- 电话号码:617-732-5087
-
-
Michigan
-
Detroit、Michigan、美国、48202
- 招聘中
- Henry Ford Health
-
接触:
- Briita Wanhala
-
首席研究员:
- Arfaat Khan, MD
-
Lansing、Michigan、美国、48910
- 主动,不招人
- McLaren Greater Lansing
-
Lansing、Michigan、美国、48912
- 招聘中
- Sparrow Clinical Research
-
接触:
- Jennifer Boak
-
首席研究员:
- Ali Sheikh, MD
-
Royal Oak、Michigan、美国、48073
- 招聘中
- William Beaumont Hospital
-
首席研究员:
- Brian Williamson, MD
-
接触:
- Greg Schlosser
-
Ypsilanti、Michigan、美国、48197
- 招聘中
- Michigan Heart
-
副研究员:
- Andrew Hughey, MD
-
接触:
- Elizabeth Goetz
-
副研究员:
- Mohammed-Ali Jazayeri, MD
-
首席研究员:
- Mohammad-Ali Jazayeri, MD
-
-
Mississippi
-
Jackson、Mississippi、美国、39202
- 招聘中
- Mississippi Baptist Medical Center
-
接触:
- Sherrina N. Dixon
-
接触:
- Greta Beatty
-
首席研究员:
- Adam Berman, MD
-
-
Missouri
-
Columbia、Missouri、美国、65212
- 招聘中
- University of Missouri
-
接触:
- Charles Donigian
-
首席研究员:
- Sandeep Gautam, MD
-
副研究员:
- Rahul Jain, MD
-
Springfield、Missouri、美国、65807
- 招聘中
- CoxHealth
-
接触:
- Sam Atkinson
-
首席研究员:
- John Garner, MD
-
副研究员:
- Scott Ferreira, MD
-
-
New Jersey
-
Haddon Heights、New Jersey、美国、08035
- 招聘中
- Cardiovascular Associates of the Delaware Valley
-
首席研究员:
- George Mark, MD
-
副研究员:
- Steven Levi, MD
-
接触:
- Kaitlyn Downey
-
副研究员:
- John Costello, DO
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87102
- 招聘中
- Lovelace Health System
-
副研究员:
- Michael Bestawros, MD
-
首席研究员:
- Sean Mazer, MD
-
副研究员:
- Michael Hoskins, MD
-
副研究员:
- Yaw Adej-Poku, MD
-
副研究员:
- Sandeep Nair, MD
-
接触:
- Alexandra Ortiz
-
-
New York
-
New York、New York、美国、10032
- 招聘中
- Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)
-
接触:
- Kate Dalton
- 电话号码:347-514-3666
- 邮箱:keb2114@cumc.columbia.edu
-
首席研究员:
- Angelo Biviano, MD
-
Poughkeepsie、New York、美国、12601
- 招聘中
- Nuvance Health
-
接触:
- Olatunde Olaniyi
-
首席研究员:
- David Steckman, MD
-
Syracuse、New York、美国、13210
- 招聘中
- Crouse Health System and Crouse Medical Practice
-
接触:
- Jennifer Peterson
- 电话号码:3154707111
- 邮箱:jenniferapeterson@crousemed.com
-
首席研究员:
- Nikhil Joshi, MD
-
-
North Carolina
-
Asheville、North Carolina、美国、28801
- 招聘中
- Mission Hospital
-
接触:
- Alex Boyd
-
首席研究员:
- Jason Lappe, MD
-
副研究员:
- Michael Manogue, MD
-
副研究员:
- John Brandt, MD
-
副研究员:
- Zachary Hale, MD
-
Winston-Salem、North Carolina、美国、27103
- 招聘中
- Novant Health Forsyth Medical Center
-
接触:
- Patricia Reece
-
首席研究员:
- Nicholas Costa, MD
-
-
Ohio
-
Cincinnati、Ohio、美国、45219
- 招聘中
- The Christ Hospital
-
首席研究员:
- Alexandru Costea, MD
-
接触:
- Anne Voorhorst
-
Cincinnati、Ohio、美国、45202
- 招聘中
- University of Cincinnati
-
接触:
- Stephanie Byrd
-
首席研究员:
- Srinivas Rajsheker, MD
-
副研究员:
- Wai Tam, MD
-
Columbus、Ohio、美国、43213
- 招聘中
- Mount Carmel Columbus Cardiology Consultants
-
首席研究员:
- Lee Gemma, MD
-
接触:
- Elissa VanKirk
- 电话号码:614-546-4327
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73120
- 招聘中
- Oklahoma Heart Hospital
-
首席研究员:
- Charles Te, MD
-
接触:
- Terri Knight
-
副研究员:
- Subha Varahan, MD
-
-
Pennsylvania
-
Lancaster、Pennsylvania、美国、17602
- 招聘中
- Lancaster General Hospital
-
首席研究员:
- Sandeep Bansal, MD
-
接触:
- Andrew Hershey
-
副研究员:
- Matthew Bernabei, MD
-
副研究员:
- Jeffrey Arkles, MD
-
Philadelphia、Pennsylvania、美国、19104
- 招聘中
- University of Pennsylvania, Penn Presbyterian Medical Center
-
首席研究员:
- Benjamin D'Souza, MD
-
接触:
- Katie Shoemaker
-
Pittsburgh、Pennsylvania、美国、15222
- 招聘中
- Allegheny Health Network
-
首席研究员:
- Joshua Silverstein, MD
-
接触:
- Caitlin Phalunas
-
副研究员:
- Amit Thosani, MD
-
副研究员:
- Emerson Liu, MD
-
副研究员:
- George Shaw, MD
-
副研究员:
- William Belding, MD
-
副研究员:
- Mati Friehling, MD
-
副研究员:
- Tharian Cherian, MD
-
York、Pennsylvania、美国、17403
- 招聘中
- WellSpan Health
-
接触:
- Elayne Grim
-
首席研究员:
- Matthew Singleton, MD
-
副研究员:
- Edmond Obeng-Gyimah, MD
-
副研究员:
- Jefferson Lee, MD
-
-
South Carolina
-
Greenville、South Carolina、美国、29607
- 招聘中
- Upstate Cardiology
-
首席研究员:
- Matthew Sellers, MD
-
接触:
- Ericka Calhoun
-
Rock Hill、South Carolina、美国、29732
- 终止
- Carolina Cardiology Associates and OnSite Clinical Solutions
-
-
Tennessee
-
Jackson、Tennessee、美国、38305
- 招聘中
- Jackson-Madison County General Hospital
-
接触:
- Cindi Thompson
- 邮箱:cindi.thompson@wth.org
-
首席研究员:
- Simon Okewole, MD
-
-
Texas
-
Austin、Texas、美国、78705
- 招聘中
- Texas Cardiac Arrhythmia Foundation
-
接触:
- Deb Cardinal
- 邮箱:dcardinal@austinheartbeat.com
-
首席研究员:
- J. David Burkhardt, MD
-
Dallas、Texas、美国、75204
- 招聘中
- Baylor Scott & White Research Institute
-
首席研究员:
- Aleem Mughal, MD
-
接触:
- Kristina Perez
-
Dallas、Texas、美国、75320
- 招聘中
- Medical City Dallas Hospital
-
接触:
- Corryn Weatherred
-
首席研究员:
- Javier Sanchez, MD
-
副研究员:
- Sunil Reddy, MD
-
副研究员:
- Kamala Tamirisa, MD
-
副研究员:
- Jodie Hurwitz, MD
-
副研究员:
- Rajeev Joshi, MD
-
-
Utah
-
Salt Lake City、Utah、美国、84124
- 招聘中
- St. Mark's Hospital
-
接触:
- Sherry Fisher
-
首席研究员:
- Nischala Nannapaneni, MD
-
-
Virginia
-
Lynchburg、Virginia、美国、24501
- 招聘中
- Centra Health, Inc. dba Stroobants Cardiovascular Center
-
首席研究员:
- Matthew Sackett, MD
-
副研究员:
- Richard Kuk, MD
-
副研究员:
- Jose Silva, MD
-
副研究员:
- Julia McHugh, MD
-
副研究员:
- Chinmaya Mareddy, MD
-
接触:
- Cindy Baumann
-
Midlothian、Virginia、美国、23114
- 招聘中
- Bon Secours St. Marys
-
接触:
- Kelly Patterson
-
首席研究员:
- An H Bui, MD
-
Richmond、Virginia、美国、23261
- 招聘中
- CJW Medical Center
-
接触:
- Ariana Dickens
-
首席研究员:
- Michael Rehorn, MD
-
Winchester、Virginia、美国、22601
- 招聘中
- Valley Health
-
接触:
- Janie Simpson
-
首席研究员:
- Emmanuel Ekanem, MD
-
-
Washington
-
Seattle、Washington、美国、98195
- 招聘中
- University of Washington-Seattle
-
首席研究员:
- Babak Nazer, MD
-
接触:
- Shiva Tabaghi, MD
- 邮箱:shiva102@uw.edu
-
Tacoma、Washington、美国、98405
- 招聘中
- MultiCare Institute for Research & Innovation
-
首席研究员:
- Tariq Salam, MD
-
副研究员:
- Jeffrey Ho, MD
-
接触:
- Kari Davidson
-
-
Wisconsin
-
Janesville、Wisconsin、美国、53548
- 招聘中
- MercyHealth
-
接触:
- Kaitlyn Phetteplace, MSN
-
首席研究员:
- Imdad Ahmed, MD
-
Madison、Wisconsin、美国、53792
- 招聘中
- University of Wisconsin
-
接触:
- Torrey Tiedman
-
首席研究员:
- Blake Fleeman, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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.
描述
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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:OTHER
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effectiveness at 90 days
大体时间:90 days
|
Freedom from arrhythmia recurrence at 90 days post procedure. |
90 days
|
|
Effectiveness at 12 months
大体时间:12 months
|
Freedom from subject reported arrhythmia recurrence through 12 months post procedure. |
12 months
|
|
Long-term Safety
大体时间:30 days post ablation
|
Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related |
30 days post ablation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Arrhythmia recurrence
大体时间:12 months
|
Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE |
12 months
|
|
Post-procedure arrhythmia treatments
大体时间:12 months
|
Treatments for arrhythmia post-procedure |
12 months
|
|
Arrhythmia related symptoms
大体时间: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
大体时间:12 months
|
Antiarrhythmic drug use (and type) post procedure and 12 months |
12 months
|
|
OAC usage
大体时间:12 months
|
Oral anticoagulant use at 12 months and drug type |
12 months
|
|
CHA2DS2VASC
大体时间: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
大体时间:12 months
|
How do you feel now compared to pre-ablation? |
12 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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