Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation (REAL-AF)

February 14, 2024 updated by: Heart Rhythm Clinical and Research Solutions, LLC

Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry

The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The REAL AF Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of Paroxysmal and Persistent ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF). Future new contact force technologies may be included as they become available in the market. Patient assessments will occur at the following time points: 1) pre-ablation, 2) procedure, 3) 10-12 weeks, 4) 6 months (monitor only) and 5) 1 year post ablation.

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 atrial arrhythmia recurrence post 90 day blanking period, and 2) acute and late onset complications.

Sites selected for this registry will already have the following pre and post procedure assessments as part of their standard of care:

Patient assessments at the following time points: (1) pre-ablation or baseline, (2) procedure, (3) 10-12 weeks, (4) 6 months (monitor only) and (5) 1 year post ablation.

Pre ablation/baseline assessment should include: TTE (within 6 months of procedure), CHADS2Vasc, sleep apnea, AAD status, OAC, Medical and Arrhythmia History 10-12 Week Follow-Up Office Visit: Physician evaluation, AAD status, OAC usage, repeat TTE, and Arrhythmia Reoccurrence and Treatment Assessment Monitoring: 96-hour continuous heart rhythm monitor scheduled at 6 months and 12 months post ablation, with an event monitor ordered as needed for symptomatic arrhythmias.

12 Month Follow up Office Visit: Physician evaluation, AF Type, AF Monitoring method, Sleep apnea, Post-procedure arrhythmia treatments, AF related symptoms and QOL improvement, AAD and OAC usage, CHA2DS2VASC and Arrhythmia Reoccurrence and Treatment Assessment

Study Type

Observational

Enrollment (Estimated)

15000

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

  • 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
        • Contact:
          • Carolyn Whitmire
          • Phone Number: cwhitmire@alcardio.com
        • 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
    • 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
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Ascension St. Vincent's
        • Principal Investigator:
          • Saumil Oza, MD
        • Contact:
          • Jasmine Vestal
        • Sub-Investigator:
          • Anthony Magnano, MD
      • 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
    • 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
      • 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
    • 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
    • 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
      • 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
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Michigan Heart
        • Principal Investigator:
          • Shrinivas Hebsur, MD
        • Sub-Investigator:
          • Andrew Hughey, MD
        • Contact:
          • Elizabeth Goetz
        • Sub-Investigator:
          • Mohammed-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
    • 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, 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, 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
    • 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

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.

Description

Inclusion Criteria:

  • Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
  • 18 years of age or older
  • De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
  • Able and willing to participate in baseline and follow up evaluations for the full length of the registry
  • 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's duration)
  • Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry
  • 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
Patients with atrial fibrillation
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 RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness at 90 days
Time Frame: 90 days
Freedom from atrial arrhythmia recurrence at 90 days post procedure.
90 days
Effectiveness at 12 months
Time Frame: 12 months
Freedom from atrial arrhythmia recurrence at 12 months post procedure.
12 months
Long-term Safety
Time Frame: Post-procedure, 3 months, and 12 months
Adverse events from post-procedure through the 12-month office visit date
Post-procedure, 3 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF 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 AF post-procedure
12 months
AF 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
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

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, 2027

Study Completion (Estimated)

December 31, 2027

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 (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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

No

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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