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This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.

Sponsor
Ablacon, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05481359
Collaborator
(none)
100
Enrollment
4
Locations
16
Anticipated Duration (Months)
25
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This post-market global registry will evaluate the ability of the Ablamap® Software to identify atrial fibrillation sources and guide ablation therapy in patients with atrial fibrillation.

Condition or Disease Intervention/Treatment Phase
  • Device: Ablamap Software

Detailed Description

The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of the Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of the Ablamap® Software to identify AF sources and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with atrial fibrillation and meet inclusion/exclusion criteria will be eligible for enrollment.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using the Ablamap® Electrographic FLOW (EGF) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
EGF-Guided Ablation Therapy

Subjects will be treated with cardiac ablation guided by the Ablamap Electrographic Flow (EGF) Mapping System.

Device: Ablamap Software
Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation.
Other Names:
  • Ablamap Electrographic Flow Algorithm Technology

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acute procedure success defined as the ability to successfully ablate AF sources identified by the Ablamap software [During the procedure]

      The ability to successfully ablate AF sources identified by the Electrographic FLOW maps of the atria pre and post ablation to determine if there is a diminished or absence of the source.

    Secondary Outcome Measures

    1. Freedom from documented episodes of AF recurrence [3-12 months]

      Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.

    2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.

    3. Subjects with a history of documented symptomatic atrial fibrillation.

    Exclusion Criteria:

    1. Subjects who are not candidates for cardiac ablation procedures.

    2. Pregnant or nursing.

    3. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Piedmont Healthcare Athens Georgia United States 30606
    3 Mercy Hospital South Saint Louis Missouri United States 63128
    4 Mount Sinai Hospital New York New York United States 10029

    Sponsors and Collaborators

    • Ablacon, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ablacon, Inc.
    ClinicalTrials.gov Identifier:
    NCT05481359
    Other Study ID Numbers:
    • CP-003
    First Posted:
    Aug 1, 2022
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    Yes
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Cardiovascular Diseases
    Heart Diseases
    Arrhythmias, Cardiac
    Pathologic Processes

    Study Results

    No Results Posted as of Aug 1, 2022