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.
NCT ID: NCT05883631
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
400 participants
INTERVENTIONAL
2023-10-23
2026-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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De Novo Arm: Electrographic Flow (EGF) mapping
Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure.
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.
Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources
Subjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Ablacon, Inc.
INDUSTRY
Cortex
INDUSTRY
Responsible Party
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Principal Investigators
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Kent Nilsson, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Athens Regional
Lucas Boersma, Prof. MD.
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Locations
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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
Countries
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Other Identifiers
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CP006
Identifier Type: -
Identifier Source: org_study_id
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