Phase
Condition
Arrhythmia
Chest Pain
Dysrhythmia
Treatment
TRUPULSE Generator
THERMOCOOL STSF Bi- Directional Navigation Catheter
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) with (a) at leasttwo symptomatic atrial fibrillation (AF) episodes within last six months fromenrollment and (b) at least one AF episode electrocardiographically documented byelectrocardiogram (ECG); transtelephonic monitoring (TTM), Holter monitor, telemetrystrip or implanted device within 12 months prior to enrollment
Failed at least one antiarrhythmic drug (AAD) (Class I or Class III) as evidenced byrecurrent symptomatic AF, intolerable side effects to the AAD, or contraindicationto the AAD
Willing and capable of providing consent
Able and willing to comply with all pre-, post- and follow-up testing andrequirements
Exclusion
Exclusion Criteria:
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiaccause (for example, documented obstructive sleep apnea, acute alcohol toxicity,etcetera)
Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
Previous left atrium (LA) ablation or surgery
Participants known to require ablation outside the pulmonary vein (PV) region (forexample, atrioventricular reentrant tachycardia, atrioventricular nodal reentrytachycardia, ventricular tachycardia, and Wolff-Parkinson-White), exceptcavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter
Documented severe dilatation of the LA (left anterior descending artery [LAD] >50mm)antero-posterior diameter on imaging within 6 months prior to enrollment
Documented LA thrombus by imaging within 48 hours of the procedure
Documented severely compromised left ventricular ejection fraction (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to enrollment
Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
History of blood clotting, bleeding abnormalities or contraindication toanticoagulation (heparin) except subjects with prior left atrial appendage closure
Documented thromboembolic event (including transient ischemic attack [TIA]) withinthe past 12 months
Participants with unstable angina, percutaneous coronary intervention or acutemyocardial infarction within 2 months
Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy,atriotomy, valve repair or replacement and presence of a prosthetic valve)
Unstable angina within 6 months
Anticipated cardiac transplantation, cardiac surgery, or other major surgery withinthe next 12 months
Significant pulmonary disease (for example, restrictive pulmonary disease,constrictive or chronic obstructive pulmonary disease) or any other disease ormalfunction of the lungs or respiratory system that produces severe chronic symptoms
Significant congenital anomaly (for example, atrial septal defects [ASDs]) includingrepaired defects or medical problem that in the opinion of the investigator wouldpreclude enrollment in this study
Prior diagnosis of pulmonary vein stenosis
Pre-existing hemi diaphragmatic paralysis
Acute illness, active systemic infection, or sepsis
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch orother abnormality that precludes catheter introduction or manipulation
Severe mitral regurgitation (Regurgitant volume greater than or equal to [>=] 60milli liter (mL)/beat, Regurgitant fraction >= 50%, and/or Effective regurgitantorifice area >= 0.40 cm^2)
Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD),recently implanted (within 6 months) left atrial appendage occlusion (LAAO) deviceor other implanted metal cardiac device within cardiac space that may interfere withthe energy field created during the ablation procedure
Presence of a condition that precludes vascular access
Current enrollment in an investigational study evaluating another device or drug
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal),lactating, or who are of child-bearing age and plan on becoming pregnant during thecourse of the clinical investigation
Life expectancy less than 12 months
Presenting contra-indications for the devices used in the study, as indicated in therespective Instructions for Use (IFU)
Study Design
Connect with a study center
Grandview Medical Center
Birmingham, Alabama 35243
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Keck School of Medicine of USC
Los Angeles, California 90033
United StatesSite Not Available
California Pacific Medical Center- Sutter Health
San Francisco, California 94109
United StatesSite Not Available
HCA Florida JFK Hospital
Atlantis, Florida 33462
United StatesSite Not Available
Ascension St. Vincent's
Jacksonville, Florida 32204
United StatesSite Not Available
HCA Florida Mercy Hospital
Miami, Florida 33133
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
Georgia Arrhythmia Consultants and Research Institute
Macon, Georgia 31201
United StatesSite Not Available
Memorial Health University Medical Center
Savannah, Georgia 31404
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
The Kansas City Heart Rhythm Institute
Overland Park, Kansas 66211
United StatesSite Not Available
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
Norton Heart Specialist
Louisville, Kentucky 40205
United StatesSite Not Available
Tulane University Heart & Vascular Institute
New Orleans, Louisiana 70112
United StatesSite Not Available
Massachusetts General
Boston, Massachusetts 02114
United StatesSite Not Available
Trinity Health Michigan Heart - Ann Arbor Campus
Ypsilanti, Michigan 48197
United StatesSite Not Available
Cooper University Hospital
Camden, New Jersey 08035
United StatesSite Not Available
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey 08035
United StatesSite Not Available
Lovelace Medical Center
Albuquerque, New Mexico 87102
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
New York University Heart Rhythm Center
New York, New York 10016
United StatesSite Not Available
New York University Langone Medical Center
New York, New York 10016
United StatesSite Not Available
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Ohio Health Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
OhioHealth Mansfield Hospital
Columbus, Ohio 43214
United StatesSite Not Available
Trident Medical Center
North Charleston, South Carolina 29406
United StatesSite Not Available
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United StatesSite Not Available
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas 75093
United StatesSite Not Available
Methodist Texsan
San Antonio, Texas 78201
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
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