Phase
Condition
Chest Pain
Dysrhythmia
Cardiac Disease
Treatment
Electrographic Flow (EGF) mapping (no ablation)
Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation
EGF-Mapping of AF Sources (no ablation)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmiasincluding atrial fibrillation, atrial flutter and/or atrial tachycardia
Above eighteen (18) years of age or of legal age to give informed consent specificto state and national law
Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichevermeasure is available or if both available, use the lesser of the two to qualify)
Exclusion
Exclusion Criteria:
De Novo paroxysmal AF
AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, orpericarditis, etc.)
Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronaryintervention, ablation for ventricular arrhythmias, left atrial appendage occlusiondevices, atrial septal defect closure devices, transcatheter aortic valvereplacement)
Presence of transvenous pacing or defibrillator leads or an atrial leadlesspacemaker
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 atrialarrhythmias
Enrollment in another investigational study evaluating another device, biologic ordrug
Study Design
Study Description
Connect with a study center
UZ Brussels
Jette, Brussels 1090
BelgiumSite Not Available
OLV Hospital Aalst
Aalst, 9300
BelgiumSite Not Available
ZNA Middelheim
Antwerp, 2020
BelgiumSite Not Available
ZOL
Genk, 3600
BelgiumSite Not Available
Neuron Medical
Brno, 625 00
CzechiaSite Not Available
IKEM (Institute for Clinical and Experimental Medicine)
Praha, 140 21
CzechiaSite Not Available
Na Homolce Hospital
Praha, 150 00
CzechiaSite Not Available
Amsterdam UMC (location AMC)
Amsterdam, North-Holland 1105AZ
NetherlandsSite Not Available
St. Antonius Hospital
Nieuwegein, Utrecht 3435CM
NetherlandsSite Not Available
Maastricht UMC+
Maastricht, 6229
NetherlandsSite Not Available
Erasmus MC
Rotterdam, 3015GD
NetherlandsSite Not Available
Grandview Medical Center
Birmingham, Alabama 35243
United StatesSite Not Available
University of Alabama
Birmingham, Alabama 35233
United StatesSite Not Available
Banner Health
Phoenix, Arizona 85006
United StatesSite Not Available
Sequoia Heart and Vascular Institute
Redwood City, California 94062
United StatesSite Not Available
Sutter Health Sequoia Heart and Vascular Institute
Redwood City, California 94062
United StatesSite Not Available
Pacific Heart Institute
Santa Monica, California 90404
United StatesSite Not Available
Colorado Heart
Golden, Colorado 80402
United StatesSite Not Available
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Ascension Medical Group
Jacksonville, Florida 32204
United StatesSite Not Available
Piedmont Health
Athens, Georgia 30606
United StatesSite Not Available
University of Illinois Health
Chicago, Illinois 60612
United StatesSite Not Available
Beaumont Health
Royal Oak, Michigan 48073
United StatesSite Not Available
Mount Sinai
New York, New York 10029
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Ohioo State University
Columbus, Ohio 43210
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Inova Health
Falls Church, Virginia 22042
United StatesSite Not Available
Evergreen Health Research/Overlake Medical Center
Bellevue, Washington 98004
United StatesSite Not Available
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