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Active, Not Recruiting

NCT Number: NCT05883631

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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Atrial Arrhythmia Atrial Fibrillation Paroxysmal Atrial Fibrillation, Paroxysmal or Persistent Atrial Fibrillation, Persistent Atrial Flutter Atrial Tachycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OLV Hospital Aalst, Aalst, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
  • Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
  • 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

  • De Novo paroxysmal AF
  • AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
  • 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)
  • Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
  • Myocardial infarction within the past 90 days
  • Severe valvular disease or prosthetic valve(s)
  • Contraindication to therapeutic anticoagulation
  • Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
  • Positive pregnancy test
  • Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
  • Enrollment in another investigational study evaluating another device, biologic or drug

Treatment and study plan

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

Device

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

Electrographic Flow (EGF) mapping (no ablation)

Device

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

Primary outcomes

  1. Number of participants with 12-month freedom from AF recurrence (with or without AADs)

    Time frame: From 90 days to 12 months after index procedure

    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).

  2. Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure

    Time frame: From index procedure to 7 days after index procedure

    Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure

  3. Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome

    Time frame: 12 months

Secondary outcomes

  1. Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure

    Time frame: From index procedure to 30 days after index procedure

    Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure

  2. Overall reduction in burden of AF for subset of patients with implantable loop recorder

    Time frame: From 90 days to 12 months after index procedure

    Evaluation of patient's freedom from AF based on recordings of implantable loop recorders

  3. Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time

    Time frame: Index or Repeat Procedure

    Evaluation of index or recurrence procedure data

Sponsors and collaborators

Lead sponsor

Cortex

Industry

Collaborators

  • Ablacon, Inc.

Registry information

Official study title

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.

Acronym: RESOLVE-AF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2023
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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