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.
- Conditions
- ArrhythmiaAtrial Fibrillation, PersistentAtrial Fibrillation ParoxysmalArrhythmias, CardiacAtrial FibrillationAtrial TachycardiaAtrial FlutterAtrial Fibrillation, Paroxysmal or PersistentAtrial Arrhythmia
- Interventions
- Device: EGF-Mapping of AF Sources (no ablation)Device: EGF-Mapping and EGF-Guided Ablation of AF Sources
- Registration Number
- NCT05883631
- Lead Sponsor
- Cortex
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description De Novo Subjects: Ablacath Mapping Catheter/Ablamap System EGF-Mapping of AF Sources (no ablation) - Redo Subjects: Ablacath Mapping Catheter/Ablamap System EGF-Mapping and EGF-Guided Ablation of AF Sources -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure 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
Overall reduction in burden of AF for subset of patients with implantable loop recorder From 90 days to 12 months after index procedure Evaluation of patient's freedom from AF based on recordings of implantable loop recorders
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time Index or Repeat Procedure Evaluation of index or recurrence procedure data
Trial Locations
- Locations (24)
University of Alabama
🇺🇸Birmingham, Alabama, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Banner Health
🇺🇸Phoenix, Arizona, United States
Ascension Medical Group
🇺🇸Jacksonville, Florida, 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
Mount Sinai Hospital
🇺🇸New York, New York, United States
Piedmont Health
🇺🇸Athens, Georgia, United States
Beaumont Health
🇺🇸Royal Oak, Michigan, 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)
🇨🇿Praha, Czechia
Amsterdam UMC (location AMC)
🇳🇱Amsterdam, North-Holland, Netherlands
Na Homolce Hospital
🇨🇿Praha, Czechia
St. Antonius Hospital
🇳🇱Nieuwegein, Utrecht, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands