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.
Running, not enrolling · Not applicable
Conditions studied: Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal, Arrhythmia, Arrhythmias, Cardiac, Atrial Flutter, Atrial Fibrillation, Paroxysmal or Persistent, Atrial Arrhythmia, Atrial Tachycardia
In brief
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.
Key facts
- Study ID
- NCT05883631
- Run by
- Cortex
- People needed
- 400
- Starts
- 2023-10-23
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-04-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- Grandview Medical Center — Birmingham, Alabama, United States
- Banner Health — Phoenix, Arizona, United States
- Sutter Health Sequoia Heart and Vascular Institute — Redwood City, California, United States
- Pacific Heart Institute — Santa Monica, California, United States
- Colorado Heart — Golden, Colorado, United States
- Florida Heart Rhythm Specialists — Fort Lauderdale, Florida, United States
- Ascension Medical Group — Jacksonville, Florida, United States
- Piedmont Health — Athens, Georgia, United States
- Beaumont Health — Royal Oak, Michigan, United States
- Mount Sinai Hospital — New York, New York, United States
- Ohio State University — Columbus, Ohio, United States
- University of Virginia — Charlottesville, Virginia, United States
- Inova Health — Falls Church, Virginia, United States
- Evergreen Health Research/Overlake Medical Center — Bellevue, Washington, United States
- 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, Netherlands
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands
- Erasmus MC — Rotterdam, Netherlands
Full record on ClinicalTrials.gov
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