Et registreringsdatabase på Faraview -teknologien i Opal HDX -kortlægningssystemet, når det bruges sammen med den fjerne nav -ablationskateter i behandlingen af atrieflimmer (OPALISE)
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Clermont-Ferrand, Frankrig
- CHRU de Clermont-Ferrand
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Grenoble, Frankrig
- CHU Grenoble
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Paris, Frankrig
- Hospital de la Pitie-Salpetriere
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Paris, Frankrig
- Hospital Europeen Georges-Pompidou (HEGP)
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Saint-Denis, Frankrig
- Centre Cardiologique du Nord
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Saint-Priest-en-Jarez, Frankrig
- CHU de Saint-Etienne
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Toulouse, Frankrig
- Clinique Pasteur
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Athens, Grækenland
- Henry Dunant Hospital Center
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Thessaloniki, Grækenland
- Ippokrateio General Hospital
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Rotterdam, Holland
- Erasmus MC- University Medical Center
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Zwolle, Holland
- Isala Klinieken
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Dublin, Irland
- Mater Private Hospital
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Mercogliano, Italien
- Clinica Montevergine
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Monaco, Monaco
- Centre Hospitalier Princesse Grace
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Lugano, Schweiz
- Cardiocentro Ticino
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Zurich, Schweiz
- University Hospital Zurich
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Bilbao, Spanien
- Hospital de Basurto
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Madrid, Spanien
- Hospital Clinico San Carlos
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Berlin, Tyskland
- Vivantes Klinikum Am Urban
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Frankfurt, Tyskland
- MVZ CCB Frankfurt und Main-Taunus GbR
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Hamburg, Tyskland
- Asklepios Klinik Saint Georg
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Vienna, Østrig
- Allgemeines Krankenhaus AKH
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
• Subjects who will undergo an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per physician's medical judgement, and according to hospitals' standard of care.
Beskrivelse
Inclusion Criteria:
- Subjects are prospectively planned and intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac 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 to this Registry at an approved clinical investigational center
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
- Subjects are planned to undergo an ablation procedure whereby the FARAWAVE NAV PF Ablation Catheter is used in conjunction with the OPAL HDx Mapping System.
Exclusion Criteria:
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary Safety Endpoint
Tidsramme: 12 months
|
The Primary Safety Endpoint is defined as the rate of device or procedure related serious adverse events following the index procedure through the 12 Month Follow-up |
12 months
|
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Primary effectiveness Endpoint
Tidsramme: 12 Months
|
The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success |
12 Months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PF337
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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