Recruiting

Catheter AblationReal-world Experience of Catheter Ablation for the Treatment of Arrhythmias

Sponsor:

Heart Rhythm Clinical and Research Solutions, LLC

Code:

NCT04088071

Conditions

Paroxysmal Atrial Fibrillation

Persistent Atrial Fibrillation

Ventricular Arrhythmia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Catheter ablation

Study Details

Brief summary:

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

Study ID

NCT04088071

Start date

Jan 1, 2018

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

Effectiveness at 90 days [ Time Frame: 90 days ]
Effectiveness at 12 months [ Time Frame: 12 months ]
Long-term Safety [ Time Frame: 30 days post ablation ]

Central Contacts and Locations

Central contacts

Jennifer White, MS

1-629-335-8261 jwhite@hrcrs.com

Jose Osorio, MD

josorio@hrcrs.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Principal Investigator:

William Maddox, MD

Grandview Medical Center

Recruiting

Birmingham, Alabama, United States, 35243

Principal Investigator:

Anil Rajendra, MD

Cardiology Associates of Mobile

Recruiting

Mobile, Alabama, United States, 36695

Principal Investigator:

Matthew Quin, MD

Valley Heart Rhythm Specialists

Recruiting

Chandler, Arizona, United States, 85224

Principal Investigator:

Huy Phan, MD

Pima Heart and Vascular

Recruiting

Tucson, Arizona, United States, 85741

Contacts

Monica Varela

5209756400 monica.varela@usheartandvascular.com

Principal Investigator:

Jitender Munjal, MD

Arrhythmia Research Group

Recruiting

Jonesboro, Arkansas, United States, 72401

Principal Investigator:

Devi Nair, MD

Keck School of Medicine

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Ivan Ho, MD

Community Memorial Hospital

Recruiting

Ventura, California, United States, 93303

Principal Investigator:

Jonathan Dukes, MD

The Medical Center of Aurora

Recruiting

Aurora, Colorado, United States, 80012

Principal Investigator:

Christopher Porterfield, MD

Colorado Heart and Vascular

Recruiting

Golden, Colorado, United States, 80401

South Denver Cardiology

Recruiting

Littleton, Colorado, United States, 80120

Principal Investigator:

Daniel Alyesh, MD

Ascension St. Vincent's

Recruiting

Jacksonville, Florida, United States, 32204

Principal Investigator:

Saumil Oza, MD

HCA Florida Mercy Hospital

Recruiting

Miami, Florida, United States, 33133

Principal Investigator:

Jose Osorio, MD

Naples Community Hospital

Recruiting

Naples, Florida, United States, 34101

Principal Investigator:

Dinesh Sharma, MD

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Principal Investigator:

Asim Ahmed, DO

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Principal Investigator:

Antonio Moretta, MD

Baycare Health Tampa

Recruiting

Tampa, Florida, United States, 33606

Contacts

Christian Kelbaugh

8132548055 christian.kelbaugh@baycare.org

Principal Investigator:

Shalin Shah, MD

Baycare Health System

Recruiting

Winterhaven, Florida, United States, 33881

Principal Investigator:

Rodrigo Bolanos, MD

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator:

Sandeep Goyal, MD

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Principal Investigator:

David Newton, MD

The Queen's Medical Center

Recruiting

Honolulu, Hawaii, United States, 97813

Principal Investigator:

David Singh, MD

Northshore University Health System

Recruiting

Evanston, Illinois, United States, 60201

Principal Investigator:

Mark Metzl, MD

Midwest Cardiovascular Institute

Recruiting

Naperville, Illinois, United States, 60540

Contacts

Sherri McCoy

630-600-0700 sherri.mccoy@cardio.com

Principal Investigator:

Kousik Krishnan, MD

Prairie Education and Research

Recruiting

Springfield, Illinois, United States, 62704

Principal Investigator:

Paban Saha, MD

Ascension St. Vincent's Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Principal Investigator:

Parin Patel, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Paari Dominic, MD

Norton Heart Specialists

Recruiting

Louisville, Kentucky, United States, 40205

Principal Investigator:

Kent Morris, MD

Baptist Health Louisville

Recruiting

Saint Matthews, Kentucky, United States, 40207

Principal Investigator:

Kevin Parrott, MD

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Principal Investigator:

Jordan Leyton-Mange, MD

Capitol CArdiology

Recruiting

Lanham, Maryland, United States, 20706

Principal Investigator:

Mohit Rastogi, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Deborah Manuelian

617-732-5087

Principal Investigator:

Paul Zei, MD, PhD

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Arfaat Khan, MD

Sparrow Clinical Research

Recruiting

Lansing, Michigan, United States, 48912

Principal Investigator:

Ali Sheikh, MD

William Beaumont Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Principal Investigator:

Brian Williamson, MD

Michigan Heart

Recruiting

Ypsilanti, Michigan, United States, 48197

Principal Investigator:

Mohammad-Ali Jazayeri, MD

Mississippi Baptist Medical Center

Recruiting

Jackson, Mississippi, United States, 39202

Principal Investigator:

Adam Berman, MD

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Principal Investigator:

Sandeep Gautam, MD

CoxHealth

Recruiting

Springfield, Missouri, United States, 65807

Principal Investigator:

John Garner, MD

Cardiovascular Associates of the Delaware Valley

Recruiting

Haddon Heights, New Jersey, United States, 08035

Principal Investigator:

George Mark, MD

Lovelace Health System

Recruiting

Albuquerque, New Mexico, United States, 87102

Principal Investigator:

Sean Mazer, MD

Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)

Recruiting

New York, New York, United States, 10032

Contacts

Kate Dalton

347-514-3666 keb2114@cumc.columbia.edu

Principal Investigator:

Angelo Biviano, MD

Nuvance Health

Recruiting

Poughkeepsie, New York, United States, 12601

Principal Investigator:

David Steckman, MD

Crouse Health System and Crouse Medical Practice

Recruiting

Syracuse, New York, United States, 13210

Contacts

Jennifer Peterson

3154707111 jenniferapeterson@crousemed.com

Principal Investigator:

Nikhil Joshi, MD

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Principal Investigator:

Jason Lappe, MD

Novant Health Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Principal Investigator:

Nicholas Costa, MD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45202

Principal Investigator:

Srinivas Rajsheker, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Alexandru Costea, MD

Mount Carmel Columbus Cardiology Consultants

Recruiting

Columbus, Ohio, United States, 43213

Contacts

Elissa VanKirk

614-546-4327

Principal Investigator:

Lee Gemma, MD

Oklahoma Heart Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Principal Investigator:

Charles Te, MD

Lancaster General Hospital

Recruiting

Lancaster, Pennsylvania, United States, 17602

Principal Investigator:

Sandeep Bansal, MD

University of Pennsylvania, Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Benjamin D'Souza, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15222

Principal Investigator:

Joshua Silverstein, MD

WellSpan Health

Recruiting

York, Pennsylvania, United States, 17403

Principal Investigator:

Matthew Singleton, MD

Upstate Cardiology

Recruiting

Greenville, South Carolina, United States, 29607

Principal Investigator:

Matthew Sellers, MD

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75204

Principal Investigator:

Aleem Mughal, MD

Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75320

Principal Investigator:

Javier Sanchez, MD

St. Mark's Hospital

Recruiting

Salt Lake City, Utah, United States, 84124

Principal Investigator:

Nischala Nannapaneni, MD

Centra Health, Inc. dba Stroobants Cardiovascular Center

Recruiting

Lynchburg, Virginia, United States, 24501

Principal Investigator:

Matthew Sackett, MD

Bon Secours St. Marys

Recruiting

Midlothian, Virginia, United States, 23114

Principal Investigator:

An H Bui, MD

CJW Medical Center

Recruiting

Richmond, Virginia, United States, 23261

Principal Investigator:

Michael Rehorn, MD

Valley Health

Recruiting

Winchester, Virginia, United States, 22601

Principal Investigator:

Emmanuel Ekanem, MD

MultiCare Institute for Research & Innovation

Recruiting

Tacoma, Washington, United States, 98405

Principal Investigator:

Tariq Salam, MD

MercyHealth

Recruiting

Janesville, Wisconsin, United States, 53548

Principal Investigator:

Imdad Ahmed, MD

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Blake Fleeman, MD

Alberta Health

Recruiting

Edmonton, Alberta, Canada, T6G2B7

Principal Investigator:

Kenneth Quadros, MD

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y2P6

Principal Investigator:

Yaariv Khaykin, MD

More Information

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

CORE VA
REAL AF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Heart Rhythm Clinical and Research Solutions, LLC on 2026-07-09.