Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias (REAL Registry)

July 7, 2026 updated by: Heart Rhythm Clinical and Research Solutions, LLC

Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias Symptomatic Using Novel CARTO Technologies: REAL 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AAD Usage
Time Frame: 12 months
Antiarrhythmic drug use (and type) post procedure and 12 months
12 months
OAC usage
Time Frame: 12 months
Oral anticoagulant use at 12 months and drug type
12 months
CHA2DS2VASC
Time Frame: 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
Time Frame: 12 months
How do you feel now compared to pre-ablation?
12 months
Arrhythmia recurrence
Time Frame: 12 months
Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE
12 months
Post-procedure arrhythmia treatments
Time Frame: 12 months
Treatments for arrhythmia post-procedure
12 months
Arrhythmia related symptoms
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Collaborators

Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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