Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Study ID
NCT04088071
Status
Recruiting
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Conditions

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Catheter ablation — DEVICE
    Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).

Study Details

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.

Key Dates

Start date
Jan 1, 2018
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Effectiveness at 90 days [ Time Frame: 90 days ]

Central Contacts

Locations (64)

FacilityCityStateZIPSite coordinators
Grandview Medical CenterBirminghamAlabama35243
Susan Thorington
Anil Rajendra, MD (PRINCIPAL_INVESTIGATOR)
Gustavo Morales, MD (SUB_INVESTIGATOR)
University of Alabama at BirminghamBirminghamAlabama35233
Michelle Osoinak
William Maddox, MD (PRINCIPAL_INVESTIGATOR)
Cardiology Associates of MobileMobileAlabama36695
Lynn Ward
Matthew Quin, MD (PRINCIPAL_INVESTIGATOR)
Valley Heart Rhythm SpecialistsChandlerArizona85224
Gianani Cabrera
Huy Phan, MD (PRINCIPAL_INVESTIGATOR)
Arrhythmia Research GroupJonesboroArkansas72401
Kayla Rubino
Devi Nair, MD (PRINCIPAL_INVESTIGATOR)
Keck School of MedicineLos AngelesCalifornia90033
Silvia Perez
Ivan Ho, MD (PRINCIPAL_INVESTIGATOR)
Junaid Zaman, PhD, MD (SUB_INVESTIGATOR)
Andrew Zadeh, MD (SUB_INVESTIGATOR)
Steven Leung, MD (SUB_INVESTIGATOR)
Santa Barbara Cottage HospitalSanta BarbaraCalifornia93105-
Community Memorial HospitalVenturaCalifornia93303
Jennifer Freeland
Jonathan Dukes, MD (PRINCIPAL_INVESTIGATOR)
University HealthCare AllianceWalnut CreekCalifornia94598-
The Medical Center of AuroraAuroraColorado80012
Chris Dutka
Christopher Porterfield, MD (PRINCIPAL_INVESTIGATOR)
Colorado Heart and VascularGoldenColorado80401
David Bailey
South Denver CardiologyLittletonColorado80120
Kathy Siegel
Daniel Alyesh, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. Vincent'sJacksonvilleFlorida32204
Jasmine Vestal
Saumil Oza, MD (PRINCIPAL_INVESTIGATOR)
Anthony Magnano, MD (SUB_INVESTIGATOR)
HCA Florida Mercy HospitalMiamiFlorida33133
Isabel Vital
Jose Osorio, MD (PRINCIPAL_INVESTIGATOR)
Naples Community HospitalNaplesFlorida34101
Anessa B Diers
Dinesh Sharma, MD (PRINCIPAL_INVESTIGATOR)
Ascension Sacred HeartPensacolaFlorida32504
Ashley Corlies
Asim Ahmed, DO (PRINCIPAL_INVESTIGATOR)
Sarasota Memorial HospitalSarasotaFlorida34239
Colleen Linder
Antonio Moretta, MD (PRINCIPAL_INVESTIGATOR)
Baycare Health SystemWinter HavenFlorida33881
Lynda Argenzio
Rodrigo Bolanos, MD (PRINCIPAL_INVESTIGATOR)
Piedmont HealthcareAtlantaGeorgia30309
Mariam Nuhu
Sandeep Goyal, MD (PRINCIPAL_INVESTIGATOR)
Michael Hoosien, MD (SUB_INVESTIGATOR)
Ashish Bhimani, MD (SUB_INVESTIGATOR)
Kavita Krishnasamy, MD (SUB_INVESTIGATOR)
Memorial Health University Medical CenterSavannahGeorgia31404
Alta Castellino, BSN
Ritzie Anne Trinidad, MBA
David Newton, MD (PRINCIPAL_INVESTIGATOR)
Todd Senn, MD (SUB_INVESTIGATOR)
The Queen's Medical CenterHonoluluHawaii97813
Beth Blackburn
David Singh, MD (PRINCIPAL_INVESTIGATOR)
Northshore University Health SystemEvanstonIllinois60201
Marisa Durante
Mark Metzl, MD (PRINCIPAL_INVESTIGATOR)
Jose Nazari, MD (SUB_INVESTIGATOR)
Alex Ro, MD (SUB_INVESTIGATOR)
Jeremiah Wasserlauf, MD (SUB_INVESTIGATOR)
Prairie Education and ResearchSpringfieldIllinois62704
Magen Kaler
Paban Saha, MD (PRINCIPAL_INVESTIGATOR)
Michael Hushion, MD (SUB_INVESTIGATOR)
Suresh Kulandhaisamy, MD (SUB_INVESTIGATOR)
Ascension St. Vincent's HospitalIndianapolisIndiana46260
Anne Renick
Parin Patel, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Trisha Elliot
Paari Dominic, MD (PRINCIPAL_INVESTIGATOR)
Norton Heart SpecialistsLouisvilleKentucky40205
Tina Abell, RN, BSN
Kent Morris, MD (PRINCIPAL_INVESTIGATOR)
Kevin Thomas, MD (SUB_INVESTIGATOR)
Hassan Khan, MD (SUB_INVESTIGATOR)
Baptist Health LouisvilleSaint MatthewsKentucky40207
Karin Cryan
Kevin Parrott, MD (PRINCIPAL_INVESTIGATOR)
Maine Medical CenterPortlandMaine04102
Joanne Burgess
Jordan Leyton-Mange, MD (PRINCIPAL_INVESTIGATOR)
Andrew Corsello, MD (SUB_INVESTIGATOR)
Henry Sesselberg, MD (SUB_INVESTIGATOR)
Edwin Sze, MD (SUB_INVESTIGATOR)
Kunal Tandon, MD (SUB_INVESTIGATOR)
Capitol CArdiologyLanhamMaryland20706
Iluyomade Adeusi
Mohit Rastogi, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Deborah Manuelian
617-732-5087
Paul Zei, MD, PhD (PRINCIPAL_INVESTIGATOR)
Jorge Romero, MD (SUB_INVESTIGATOR)
Nathaniel Steiger, MD (SUB_INVESTIGATOR)
Thomas Tadros, MD (SUB_INVESTIGATOR)
Henry Ford HealthDetroitMichigan48202
Briita Wanhala
Arfaat Khan, MD (PRINCIPAL_INVESTIGATOR)
McLaren Greater LansingLansingMichigan48910-
Sparrow Clinical ResearchLansingMichigan48912
Jennifer Boak
Ali Sheikh, MD (PRINCIPAL_INVESTIGATOR)
William Beaumont HospitalRoyal OakMichigan48073
Greg Schlosser
Brian Williamson, MD (PRINCIPAL_INVESTIGATOR)
Michigan HeartYpsilantiMichigan48197
Elizabeth Goetz
Mohammad-Ali Jazayeri, MD (PRINCIPAL_INVESTIGATOR)
Andrew Hughey, MD (SUB_INVESTIGATOR)
Mohammed-Ali Jazayeri, MD (SUB_INVESTIGATOR)
Mississippi Baptist Medical CenterJacksonMississippi39202
Sherrina N. Dixon
Greta Beatty
Adam Berman, MD (PRINCIPAL_INVESTIGATOR)
University of MissouriColumbiaMissouri65212
Charles Donigian
Sandeep Gautam, MD (PRINCIPAL_INVESTIGATOR)
Rahul Jain, MD (SUB_INVESTIGATOR)
CoxHealthSpringfieldMissouri65807
Sam Atkinson
John Garner, MD (PRINCIPAL_INVESTIGATOR)
Scott Ferreira, MD (SUB_INVESTIGATOR)
Cardiovascular Associates of the Delaware ValleyHaddon HeightsNew Jersey08035
Kaitlyn Downey
George Mark, MD (PRINCIPAL_INVESTIGATOR)
John Costello, DO (SUB_INVESTIGATOR)
Steven Levi, MD (SUB_INVESTIGATOR)
Lovelace Health SystemAlbuquerqueNew Mexico87102
Alexandra Ortiz
Sean Mazer, MD (PRINCIPAL_INVESTIGATOR)
Michael Hoskins, MD (SUB_INVESTIGATOR)
Michael Bestawros, MD (SUB_INVESTIGATOR)
Yaw Adej-Poku, MD (SUB_INVESTIGATOR)
Sandeep Nair, MD (SUB_INVESTIGATOR)
Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)New YorkNew York10032
Kate Dalton
[email protected]
347-514-3666
Nuvance HealthPoughkeepsieNew York12601
Olatunde Olaniyi
David Steckman, MD (PRINCIPAL_INVESTIGATOR)
Mission HospitalAshevilleNorth Carolina28801
Alex Boyd
Jason Lappe, MD (PRINCIPAL_INVESTIGATOR)
Michael Manogue, MD (SUB_INVESTIGATOR)
John Brandt, MD (SUB_INVESTIGATOR)
Zachary Hale, MD (SUB_INVESTIGATOR)
Novant Health Forsyth Medical CenterWinston-SalemNorth Carolina27103
Patricia Reece
Nicholas Costa, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Anne Voorhorst
Alexandru Costea, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45202
Stephanie Byrd
Srinivas Rajsheker, MD (PRINCIPAL_INVESTIGATOR)
Wai Tam, MD (SUB_INVESTIGATOR)
Mount Carmel Columbus Cardiology ConsultantsColumbusOhio43213
Elissa VanKirk
614-546-4327
Lee Gemma, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Heart HospitalOklahoma CityOklahoma73120
Terri Knight
Charles Te, MD (PRINCIPAL_INVESTIGATOR)
Subha Varahan, MD (SUB_INVESTIGATOR)
Lancaster General HospitalLancasterPennsylvania17602
Andrew Hershey
Sandeep Bansal, MD (PRINCIPAL_INVESTIGATOR)
Matthew Bernabei, MD (SUB_INVESTIGATOR)
Jeffrey Arkles, MD (SUB_INVESTIGATOR)
University of Pennsylvania, Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104
Katie Shoemaker
Benjamin D'Souza, MD (PRINCIPAL_INVESTIGATOR)
Allegheny Health NetworkPittsburghPennsylvania15222
Caitlin Phalunas
Joshua Silverstein, MD (PRINCIPAL_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 (SUB_INVESTIGATOR)
WellSpan HealthYorkPennsylvania17403
Elayne Grim
Matthew Singleton, MD (PRINCIPAL_INVESTIGATOR)
Edmond Obeng-Gyimah, MD (SUB_INVESTIGATOR)
Jefferson Lee, MD (SUB_INVESTIGATOR)
Upstate CardiologyGreenvilleSouth Carolina29607
Ericka Calhoun
Matthew Sellers, MD (PRINCIPAL_INVESTIGATOR)
Carolina Cardiology Associates and OnSite Clinical SolutionsRock HillSouth Carolina29732-
Baylor Scott & White Research InstituteDallasTexas75204
Kristina Perez
Aleem Mughal, MD (PRINCIPAL_INVESTIGATOR)
Medical City Dallas HospitalDallasTexas75320
Corryn Weatherred
Javier Sanchez, MD (PRINCIPAL_INVESTIGATOR)
Sunil Reddy, MD (SUB_INVESTIGATOR)
Kamala Tamirisa, MD (SUB_INVESTIGATOR)
Jodie Hurwitz, MD (SUB_INVESTIGATOR)
Rajeev Joshi, MD (SUB_INVESTIGATOR)
St. Mark's HospitalSalt Lake CityUtah84124
Sherry Fisher
Nischala Nannapaneni, MD (PRINCIPAL_INVESTIGATOR)
Centra Health, Inc. dba Stroobants Cardiovascular CenterLynchburgVirginia24501
Cindy Baumann
Matthew Sackett, MD (PRINCIPAL_INVESTIGATOR)
Richard Kuk, MD (SUB_INVESTIGATOR)
Jose Silva, MD (SUB_INVESTIGATOR)
Julia McHugh, MD (SUB_INVESTIGATOR)
Chinmaya Mareddy, MD (SUB_INVESTIGATOR)
Bon Secours St. MarysMidlothianVirginia23114
Kelly Patterson
An H Bui, MD (PRINCIPAL_INVESTIGATOR)
CJW Medical CenterRichmondVirginia23261
Ariana Dickens
Michael Rehorn, MD (PRINCIPAL_INVESTIGATOR)
Valley HealthWinchesterVirginia22601
Janie Simpson
Emmanuel Ekanem, MD (PRINCIPAL_INVESTIGATOR)
MultiCare Institute for Research & InnovationTacomaWashington98405
Kari Davidson
Tariq Salam, MD (PRINCIPAL_INVESTIGATOR)
Jeffrey Ho, MD (SUB_INVESTIGATOR)
MercyHealthJanesvilleWisconsin53548
Kaitlyn Phetteplace, MSN
Imdad Ahmed, MD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53792
Torrey Tiedman
Blake Fleeman, MD (PRINCIPAL_INVESTIGATOR)

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