NCT05883631Active, not recruiting
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.
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.
Source: ClinicalTrials.gov · Last updated 13 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 22 May 2023
- Start date
- 23 Oct 2023
- Primary completion date
- Jan 2026
- Lead sponsor
- Cortex
- Diseases
- Atrial fibrillation
- NCT number
- NCT05883631
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 23 Oct 2023 to the primary completion date, Jan 2026
- 24 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
- Enrollment in another investigational study evaluating another device, biologic or drug
Other illness
- 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)
- Myocardial infarction within the past 90 days
- Severe valvular disease or prosthetic valve(s)
- Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
- Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
Other
- De Novo paroxysmal AF
- Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
- Contraindication to therapeutic anticoagulation
- Positive pregnancy test
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLV Hospital Aalst Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| ZNA Middelheim Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| ZOL Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| Neuron Medical Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Na Homolce Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| IKEM Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Amsterdam UMC, location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Piedmont Health Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
| Evergreen Health Research/Overlake Medical Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Grandview Medical Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Inova Health Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Florida Heart Rhythm Specialists Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Colorado Heart Coordinator of this site? Confirm its status | Golden | United States | Unknown status |
| Ascension Medical Group Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Banner Health Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Sutter Health Sequoia Heart and Vascular Institute Coordinator of this site? Confirm its status | Redwood City | United States | Unknown status |
| Beaumont Health Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Pacific Heart Institute Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.