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. (RESOLVE-AF)

Prospective, Single Arm, Multi-center, Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-pulmonary Vein Sources of Atrial Fibrillation and Guide Ablation Therapy.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Arrhythmia; Atrial Flutter; Atrial Fibrillation, Persistent; Atrial Tachycardia; Atrial Arrhythmia; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Paroxysmal or Persistent
• Intervention / Treatment: Device: Electrographic Flow (EGF) mapping (no ablation); Device: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Hospital Aalst
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Genk, Belgium, 3600
    • ZOL
• Czechia
  • Brno, Czechia, 625 00
    • Neuron Medical
  • Praha, Czechia, 140 21
    • IKEM (Institute for Clinical and Experimental Medicine)
  • Praha, Czechia, 150 00
    • Na Homolce Hospital
• Netherlands
  • Rotterdam, Netherlands, 3015GD
    • Erasmus MC
  • North-Holland
    • Amsterdam, North-Holland, Netherlands, 1105AZ
      • Amsterdam UMC (location AMC)
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • St. Antonius Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
    • Birmingham, Alabama, United States, 35233
      • University of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Health
  • California
    • Redwood City, California, United States, 94062
      • Sutter Health Sequoia Heart and Vascular Institute
    • Santa Monica, California, United States, 90404
      • Pacific Heart Institute
  • Colorado
    • Golden, Colorado, United States, 80402
      • Colorado Heart
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Florida Heart Rhythm Specialists
    • Jacksonville, Florida, United States, 32204
      • Ascension Medical Group
  • Georgia
    • Athens, Georgia, United States, 30606
      • Piedmont Health
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • INOVA Health
  • Washington
    • Bellevue, Washington, United States, 98004
      • Evergreen Health Research/Overlake Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
3. Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichever measure is available or if both available, use the lesser of the two to qualify)

Exclusion Criteria:

1. De Novo paroxysmal AF
2. AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
3. Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronary intervention, ablation for ventricular arrhythmias, left atrial appendage occlusion devices, atrial septal defect closure devices, transcatheter aortic valve replacement)
4. Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
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 atrial arrhythmias
11. Enrollment in another investigational study evaluating another device, biologic or drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: De Novo Arm: Electrographic Flow (EGF) mapping; Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure.	Device: Electrographic Flow (EGF) mapping (no ablation); In addition to standard pulmonary vein isolation (PVI), subjects receive Electrographic Flow™ (EGF) mapping. PVI may be performed using any commercially available platform/catheter. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF-identified sources with activity above the threshold (≥ 25%) are marked as relevant; however, no EGF-guided ablations are performed during this index procedure. If subjects have AF recurrence after the 90-day blanking period, they may undergo a recurrence procedure and EGF-guided ablation.; Other Names: OptiMap™ System
Experimental: Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources; Subjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure.	Device: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation; In addition to standard touch-up of pulmonary vein isolation, subjects receive targeted source ablation guided by Electrographic Flow™ (EGF) mapping. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF-identified sources with activity above the threshold (≥ 25%) are considered significant and targeted with radiofrequency ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.; Other Names: OptiMap™ System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with 12-month freedom from AF recurrence (with or without AADs)	This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up (with or without AADs).	From 90 days to 12 months after index procedure
Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure	Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure	From index procedure to 7 days after index procedure
Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure	Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure	From index procedure to 30 days after index procedure
Overall reduction in burden of AF for subset of patients with implantable loop recorder	Evaluation of patient's freedom from AF based on recordings of implantable loop recorders	From 90 days to 12 months after index procedure
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time	Evaluation of index or recurrence procedure data	Index or Repeat Procedure

Collaborators and Investigators

• Sponsor: Cortex
• Collaborators: Ablacon, Inc.
• Investigators: Principal Investigator: Lucas Boersma, Prof. MD., St. Antonius Hospital; Principal Investigator: Kent Nilsson, MD, Piedmont Athens Regional

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Atrial Fibrillation; Tachycardia; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: CP006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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