RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

Last updated: April 9, 2025
Sponsor: Cortex
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Cardiac Disease

Treatment

Electrographic Flow (EGF) mapping (no ablation)

Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation

EGF-Mapping of AF Sources (no ablation)

Clinical Study ID

NCT05883631
CP006
  • Ages 18-80
  • All Genders

Study Summary

Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures.

Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmiasincluding atrial fibrillation, atrial flutter and/or atrial tachycardia

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

  3. Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichevermeasure is available or if both available, use the lesser of the two to qualify)

Exclusion

Exclusion Criteria:

  1. De Novo paroxysmal AF

  2. AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, orpericarditis, etc.)

  3. Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronaryintervention, ablation for ventricular arrhythmias, left atrial appendage occlusiondevices, atrial septal defect closure devices, transcatheter aortic valvereplacement)

  4. Presence of transvenous pacing or defibrillator leads or an atrial leadlesspacemaker

  5. Myocardial infarction within the past 90 days

  6. Severe valvular disease or prosthetic valve(s)

  7. Contraindication to therapeutic anticoagulation

  8. Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV

  9. Positive pregnancy test

  10. Any other contraindication to an intracardiac mapping and ablation of atrialarrhythmias

  11. Enrollment in another investigational study evaluating another device, biologic ordrug

Study Design

Total Participants: 400
Treatment Group(s): 5
Primary Treatment: Electrographic Flow (EGF) mapping (no ablation)
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
January 31, 2026

Study Description

Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.

Connect with a study center

  • UZ Brussels

    Jette, Brussels 1090
    Belgium

    Site Not Available

  • OLV Hospital Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • ZNA Middelheim

    Antwerp, 2020
    Belgium

    Site Not Available

  • ZOL

    Genk, 3600
    Belgium

    Site Not Available

  • Neuron Medical

    Brno, 625 00
    Czechia

    Site Not Available

  • IKEM (Institute for Clinical and Experimental Medicine)

    Praha, 140 21
    Czechia

    Site Not Available

  • Na Homolce Hospital

    Praha, 150 00
    Czechia

    Site Not Available

  • Amsterdam UMC (location AMC)

    Amsterdam, North-Holland 1105AZ
    Netherlands

    Site Not Available

  • St. Antonius Hospital

    Nieuwegein, Utrecht 3435CM
    Netherlands

    Site Not Available

  • Maastricht UMC+

    Maastricht, 6229
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015GD
    Netherlands

    Site Not Available

  • Grandview Medical Center

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • University of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Banner Health

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Sequoia Heart and Vascular Institute

    Redwood City, California 94062
    United States

    Site Not Available

  • Sutter Health Sequoia Heart and Vascular Institute

    Redwood City, California 94062
    United States

    Site Not Available

  • Pacific Heart Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Colorado Heart

    Golden, Colorado 80402
    United States

    Site Not Available

  • Florida Heart Rhythm Specialists

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Ascension Medical Group

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Piedmont Health

    Athens, Georgia 30606
    United States

    Site Not Available

  • University of Illinois Health

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Beaumont Health

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Ohioo State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Inova Health

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Evergreen Health Research/Overlake Medical Center

    Bellevue, Washington 98004
    United States

    Site Not Available

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