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Clinical Trials in the Netherlands / NCT05883631
Active, not recruiting Not applicable

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.

NCT05883631 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Cortex
Phase
Not applicable
Started
2023-10-23
Last updated
2025-04-13

Condition(s) studied

Atrial FibrillationAtrial Fibrillation, PersistentAtrial Fibrillation ParoxysmalArrhythmiaArrhythmias, CardiacAtrial FlutterAtrial Fibrillation, Paroxysmal or PersistentAtrial ArrhythmiaAtrial Tachycardia

Investigational drug(s) / intervention(s)

Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial FibrillationElectrographic Flow (EGF) mapping (no ablation)

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.

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.

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with 12-month freedom from AF recurrence (with or without AADs) — 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).
  • Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure — 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
  • Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome — 12 months

Trial sites (24)

FacilityCityRegionStatus
University of Alabama Birmingham Alabama
Grandview Medical Center Birmingham Alabama
Banner Health Phoenix Arizona
Sutter Health Sequoia Heart and Vascular Institute Redwood City California
Pacific Heart Institute Santa Monica California
Colorado Heart Golden Colorado
Florida Heart Rhythm Specialists Fort Lauderdale Florida
Ascension Medical Group Jacksonville Florida
Piedmont Health Athens Georgia
Beaumont Health Royal Oak Michigan
Mount Sinai Hospital New York New York
Ohio State University Columbus Ohio
University of Virginia Charlottesville Virginia
Inova Health Falls Church Virginia
Evergreen Health Research/Overlake Medical Center Bellevue Washington
OLV Hospital Aalst Aalst Belgium
ZNA Middelheim Antwerp Belgium
ZOL Genk Belgium
Neuron Medical Brno Czechia
IKEM (Institute for Clinical and Experimental Medicine) Prague Czechia
Na Homolce Hospital Prague Czechia
Amsterdam UMC (location AMC) Amsterdam North Holland
St. Antonius Hospital Nieuwegein Utrecht
Erasmus MC Rotterdam Netherlands

Other trials for the same condition

The Multicenter Cardiology Monitoring Platform Registry Recruiting
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation Active, not recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Recruiting
ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05883631 on ClinicalTrials.gov ↗ ← All trials in the Netherlands