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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (12 items).
Location: University of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (24 Sites)
- 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,
- ZNA Middelheim — Antwerp,
- ZOL — Genk,
- Neuron Medical — Brno,
- IKEM (Institute for Clinical and Experimental Medicine) — Prague,
- Na Homolce Hospital — Prague,
- Amsterdam UMC (location AMC) — Amsterdam, North Holland
- St. Antonius Hospital — Nieuwegein, Utrecht
- Erasmus MC — Rotterdam,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.