Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Vektor Medical
Study ID
NCT06935591
Status
Recruiting
Apply to this trial

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

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

Interventions

  • Pulmonary Vein Isolation — PROCEDURE
    Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.
  • vMap® + Pulmonary Vein Isolation — DEVICE
    Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.

Study Details

The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults. Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).

Key Dates

Start date
Jun 27, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
423 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: vMap®+PVI
    Subjects in this arm will be treated with the use of the vMap® system in addition to pulmonary vein isolation.
  • Active Comparator: PVI Alone
    Subjects in this arm will be treated with pulmonary vein isolation alone.

Primary Outcome Measure

Freedom from AF [ Time Frame: 12 months post procedure ]

Locations (12)

FacilityCityStateZIPSite coordinators
Arrhythmia Research Group - St. BernardsJonesboroArkansas72401
Kayla Rubino
[email protected]
870-935-6729
Devi Nair, MD (PRINCIPAL_INVESTIGATOR)
BayCare Health SystemClearwaterFlorida33759
Andrea Daigneault
[email protected]
727-461-8510
Vaibhav Moondra, MD (PRINCIPAL_INVESTIGATOR)
Cydney Rebetti, APRN (SUB_INVESTIGATOR)
Baptist Health JacksonvilleJacksonvilleFlorida32207
Smitha Gubbi
[email protected]
904-202-7069
Matthew S McKillop, MD (PRINCIPAL_INVESTIGATOR)
Steven Ross, MD (SUB_INVESTIGATOR)
Christopher Ruisi, MD (SUB_INVESTIGATOR)
USF HealthTampaFlorida33606
Jacky He
[email protected]
813-396-0410
Executive Director, Clinical Operations
[email protected]
813-974-3823
David Wilson, MD (PRINCIPAL_INVESTIGATOR)
Bengt Herweg, MD (SUB_INVESTIGATOR)
Christopher Cook, MD (SUB_INVESTIGATOR)
Piedmont Heart of AthensAthensGeorgia30606
Caryn Bernstein
[email protected]
404-605-5688
Kent Nilsson, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Heart InstituteAtlantaGeorgia30309
Caryn Bernstein
[email protected]
404-605-5688
Sandeep Goyal, MD (PRINCIPAL_INVESTIGATOR)
Ashish Bhimani, MD (SUB_INVESTIGATOR)
Michael Hoosien, MD (SUB_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Collin Lamothe
[email protected]
317-274-0963
Mithilesh Das, MD (PRINCIPAL_INVESTIGATOR)
John Miller, MD (SUB_INVESTIGATOR)
Baptist Health LexigntonLexingtonKentucky40503
Gwyndolyn Middleton
[email protected]
859-260-4445
Franklin Gonzalez
[email protected]
859-260-3197
Gery Tomassoni, MD (PRINCIPAL_INVESTIGATOR)
Johan Aasbo, MD (SUB_INVESTIGATOR)
John Lee, MD (SUB_INVESTIGATOR)
Joel Simon, MD (SUB_INVESTIGATOR)
Westchester Medical CenterValhallaNew York10595
Corazon De La Pena
[email protected]
914-493-2483
Sei Iwai, MD (PRINCIPAL_INVESTIGATOR)
Jason Jacobson, MD (SUB_INVESTIGATOR)
Daniel Frenkel, MD (SUB_INVESTIGATOR)
Rhadames Rojas, MD (SUB_INVESTIGATOR)
Subrat Das, MD (SUB_INVESTIGATOR)
Sade Solola-Nussbaum, MD (SUB_INVESTIGATOR)
Sayaka Larsen, RN (SUB_INVESTIGATOR)
Tracey Shannon, NP, RN (SUB_INVESTIGATOR)
Nyree Sencion-Akhtar, DNP, FNP-C, RN (SUB_INVESTIGATOR)
OhioHealthColumbusOhio43202
Reem Bekheet
[email protected]
937-218-3542
Anish Amin, MD (PRINCIPAL_INVESTIGATOR)
Sreedhar Billakanty, MD (SUB_INVESTIGATOR)
Auroa Badin, MD (SUB_INVESTIGATOR)
Nagesh Chopra, MD (SUB_INVESTIGATOR)
Jaret Tyler, MD (SUB_INVESTIGATOR)
Ankur Shah, MD (SUB_INVESTIGATOR)
Eugene Fu, MD (SUB_INVESTIGATOR)
University of Toledo Medical CenterToledoOhio43614
Christina Sattler
[email protected]
419-383-6225
Abhishek Maan, MD (PRINCIPAL_INVESTIGATOR)
Penn PresbyterianPhiladelphiaPennsylvania19104-4238
Katie Shoemaker
[email protected]
215-662-8562
Benjamin D'Souza, MD (PRINCIPAL_INVESTIGATOR)

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Arrhythmia Research Group - St. Bernards· Jonesboro, ARBayCare Health System· Clearwater, FLBaptist Health Jacksonville· Jacksonville, FLUSF Health· Tampa, FLPiedmont Heart of Athens· Athens, GAPiedmont Heart Institute· Atlanta, GA

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