Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
Purpose
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.
Conditions
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
- Ventricular Arrhythmia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
| 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. |
|
Recruiting Locations
Birmingham, Alabama 35233
Michelle Osoinak
Birmingham, Alabama 35243
Susan Thorington
Mobile, Alabama 36695
Lynn Ward
Chandler, Arizona 85224
Gianani Cabrera
Tucson, Arizona 85741
Jonesboro, Arkansas 72401
Kayla Rubino
Los Angeles, California 90033
Silvia Perez
Ventura, California 93303
Jennifer Freeland
Aurora, Colorado 80012
Chris Dutka
Golden, Colorado 80401
David Bailey
Littleton, Colorado 80120
Kathy Siegel
Jacksonville, Florida 32204
Jasmine Vestal
Miami, Florida 33133
Isabel Vital
Naples, Florida 34101
Anessa B Diers
Pensacola, Florida 32504
Ashley Corlies
Sarasota, Florida 34239
Colleen Linder
Tampa, Florida 33606
Winterhaven, Florida 33881
Lynda Argenzio
Atlanta, Georgia 30309
Mariam Nuhu
Savannah, Georgia 31404
Alta Castellino, BSN
Honolulu, Hawaii 97813
Beth Blackburn
Evanston, Illinois 60201
Marisa Durante
Naperville, Illinois 60540
Springfield, Illinois 62704
Magen Kaler
Indianapolis, Indiana 46260
Anne Renick
Iowa City, Iowa 52242
Trisha Elliot
Louisville, Kentucky 40205
Tina Abell, RN, BSN
Saint Matthews, Kentucky 40207
Karin Cryan
Portland, Maine 04102
Joanne Burgess
Lanham, Maryland 20706
Iluyomade Adeusi
Boston, Massachusetts 02115
Deborah Manuelian
617-732-5087
Detroit, Michigan 48202
Briita Wanhala
Lansing, Michigan 48912
Jennifer Boak
Royal Oak, Michigan 48073
Greg Schlosser
Ypsilanti, Michigan 48197
Elizabeth Goetz
Jackson, Mississippi 39202
Sherrina N. Dixon
Columbia, Missouri 65212
Charles Donigian
Springfield, Missouri 65807
Sam Atkinson
Haddon Heights, New Jersey 08035
Kaitlyn Downey
Albuquerque, New Mexico 87102
Alexandra Ortiz
New York, New York 10032
Poughkeepsie, New York 12601
Olatunde Olaniyi
Syracuse, New York 13210
Asheville, North Carolina 28801
Alex Boyd
Winston-Salem, North Carolina 27103
Patricia Reece
Cincinnati, Ohio 45202
Stephanie Byrd
Cincinnati, Ohio 45219
Anne Voorhorst
Columbus, Ohio 43213
Elissa VanKirk
614-546-4327
Oklahoma City, Oklahoma 73120
Terri Knight
Lancaster, Pennsylvania 17602
Andrew Hershey
Philadelphia, Pennsylvania 19104
Katie Shoemaker
Pittsburgh, Pennsylvania 15222
Caitlin Phalunas
York, Pennsylvania 17403
Elayne Grim
Greenville, South Carolina 29607
Ericka Calhoun
Dallas, Texas 75204
Kristina Perez
Dallas, Texas 75320
Corryn Weatherred
Salt Lake City, Utah 84124
Sherry Fisher
Lynchburg, Virginia 24501
Cindy Baumann
Midlothian, Virginia 23114
Kelly Patterson
Richmond, Virginia 23261
Ariana Dickens
Winchester, Virginia 22601
Janie Simpson
Tacoma, Washington 98405
Kari Davidson
Janesville, Wisconsin 53548
Kaitlyn Phetteplace, MSN
Madison, Wisconsin 53792
Torrey Tiedman
More Details
- Status
- Recruiting
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Detailed Description
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.