Phase
Condition
Dysrhythmia
Chest Pain
Arrhythmia
Treatment
FARAPULSE Pulsed Field Ablation system
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system forcardiac tissue ablation, per physician's medical judgement, and as per hospitals'standard of care
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing associated withthis clinical study at an approved clinical investigational center
Subjects whose age is 18 years or above, or who are of legal age to give informedconsent specific to state and national law
Exclusion
Exclusion Criteria:
Subjects with a current interatrial baffle or patch
Subjects with a known or suspected atrial myxoma
Subjects with a myocardial infarction within 14 days prior to enrollment
Subjects with a recent (within 30 days prior to enrollment) Cerebral VascularAccident (CVA)
Subjects who do not tolerate anticoagulation therapy
Subjects with an active systemic infection *
Subjects with a presence of atrial known thrombus *
Subjects with a known inability to obtain vascular access
Subjects who are pregnant or planning to be pregnant
Subjects with atrial fibrillation that is secondary to electrolyte imbalance,thyroid disease, alcohol, or other reversible / non-cardiac causes
Subjects with any prosthetic heart valve, ring or repair including balloon aorticvalvuloplasty
Subjects with a contraindication to an invasive electrophysiology procedure whereinsertion or manipulation of a catheter in the cardiac chambers is deemed unsafe perphysician's medical judgement, such as, but not limited to, a recent previouscardiac surgery (eg. ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stentprocedure/unstable angina) and/or in patients with congenital heart disease wherethe underlying abnormality increases the risk of the ablation (e.g., severerotational anomalies of the heart or great vessels)
Subjects with a life expectancy of ≤ 1 year per investigator's opinion
Subjects who are currently enrolled in another investigational study or registrythat would directly interfere with the current study, except when the subject isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance must be brought to theattention of the sponsor to determine eligibility
Study Design
Study Description
Connect with a study center
Prince Charles Hospital
Brisbane,
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch,
AustraliaSite Not Available
John Hunter Hospital
Newcastle,
AustraliaSite Not Available
Allgemeines Krankenhaus AKH
Vienna,
AustriaSite Not Available
AZ Sint Jan Hospital
Brugge,
BelgiumSite Not Available
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Hasselt,
BelgiumSite Not Available
CHR de la Citadelle
Liège,
BelgiumSite Not Available
Neuron Medical in Brno
Brno,
CzechiaSite Not Available
Nemocnice Ceske Budejovice a.s.
České Budějovice,
CzechiaSite Not Available
Tays Heart Hospital
Tampere,
FinlandSite Not Available
CHU Grenoble
Grenoble,
FranceSite Not Available
Hopital Saint Philibert-Hospital
Lomme,
FranceSite Not Available
Hopital Prive du Confluent SAS
Nantes,
FranceSite Not Available
Clinique Ambroise Pare-Hospital
Neuilly,
FranceSite Not Available
Centre Cardiologique du Nord
Saint-Denis,
FranceSite Not Available
Clinique Pasteur Toulouse
Toulouse,
FranceSite Not Available
Universitaetsklinikum Aachen (UKA)
Aachen,
GermanySite Not Available
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
Dresden,
GermanySite Not Available
Georg-August-Universitaet Goettingen
Göttingen,
GermanySite Not Available
St Georg Asklepios
Hamburg,
GermanySite Not Available
Universitaetsklinikum Heidelberg
Heidelberg,
GermanySite Not Available
Staedisches Klinikum Karlsruhe
Karlsruhe,
GermanySite Not Available
University Hospital of Muenster
Münster,
GermanySite Not Available
Henry Dunant hospital
Athens,
GreeceSite Not Available
Onassis Cardiac Surgery Center
Athens,
GreeceSite Not Available
Prince of Wales Hospital
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Semmelweis University
Budapest,
HungarySite Not Available
Mater Private Hospital
Dublin,
IrelandSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv,
IsraelSite Not Available
Az. Osp. Lancisi-Hospital
Ancona,
ItalySite Not Available
Casa Di Cura 'Montevergine' S.P.A.
Mercogliano,
ItalySite Not Available
Ospedale Rivoli
Rivoli,
ItalySite Not Available
Ospedale Isola Tiberina Gemelli Isola
Roma,
ItalySite Not Available
Ospedale San Bortolo de Vicenza
Vicenza,
ItalySite Not Available
Institut Jantung Negara
Kuala Lumpur,
MalaysiaSite Not Available
Princesse Grace
Monaco,
MonacoSite Not Available
Catharina Ziekenhuis
Eindhoven,
NetherlandsSite Not Available
St. Antonius Ziekenhuis
Nieuwegein,
NetherlandsSite Not Available
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw,
PolandSite Not Available
Hospital de Santa Cruz
Carnaxide,
PortugalSite Not Available
King Fahd Armed Forces Hospital
Jeddah,
Saudi ArabiaSite Not Available
Centro Especial Ramon y Cajal
Madrid,
SpainSite Not Available
Clinica Universidad de Navarra
Pamplona,
SpainSite Not Available
Hospital Universitario La Fe
Valencia,
SpainSite Not Available
Hospital Clinico Universitario Lozano Blesa
Zaragosa,
SpainSite Not Available
Royal Papworth Hospital
Cambridge,
United KingdomSite Not Available
Liverpool Heart & Chest Hospital
Liverpool,
United KingdomSite Not Available
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