- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06762717
Eine beobachtende, prospektive, nicht randomisierte, einarmige, multizentrische Post-Market-Studie zum FARAPULSE™
Reale Datenerfassung in der chinesischen Bevölkerung, die mit dem FARAPULSE™ Pulsed Field Ablation System behandelt wurde
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study.
All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE™ PFA system will be followed for three years.
Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
China/Beijing
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Beijing, China/Beijing, China, 100037
- Fuwai Hospital, Chinese Academy of Medical Sciences
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE™ Pulsed Field Ablation system, per indication approved in China, per physician's medical judgement, and according to hospitals' standard of care
Beschreibung
Inclusion Criteria:
- Subjects 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 in all testing associated with this clinical study at an approved clinical investigational center
- Subjects whose age is 18 years or above.
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 Vascular Accident (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 aortic valvuloplasty
- Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure), recent previous unstable angina and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational 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 registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: OTHER
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Failure-free rate
Zeitfenster: 12 Months
|
Failure-free rate at 12 Month post index procedure. |
12 Months
|
|
Device-or procedure-related SAEs:
Zeitfenster: 7 days and 12 months
|
Composite of the following device- or procedure-related SAEs: |
7 days and 12 months
|
|
Procedure- and device related adverse events
Zeitfenster: 12 Months and 2 years and 3 years
|
All FARAPULSE™ PFA procedure- and device related adverse events at 12 Month, 2 Year and 3 Year follow-up. |
12 Months and 2 years and 3 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Min Tang, Dr, Chinese Academy of Medical Sciences, Fuwai Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PF333
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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