"EASE" Epicardial Access With the EpiAccess System (EASE2)
EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
Studieoversikt
Detaljert beskrivelse
Prior to enrolment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be enrolled in the study by the local principal investigator after informed consent is obtained.
As EpiAccess is only used for the access portion of electrophysiology procedures, the safety, performance and effectiveness endpoints are acute from the time of needle insertion to pericardial space access (guidewire insertion into the pericardial sac). Patients will be followed until hospital discharge. Follow-up clinical examinations will be performed in accordance with institutions' standard of care. No special tests are required for this device. Patients' completion of study will occur at the time of their hospital discharge, or earlier if patient did not complete the study.
The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as defined in this protocol, after enrolment of 10 or more patients, compared to existing data from the literature presenting epicardial access procedure results during sub-xyphoid (minimally invasive) surgical procedures.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Prague, Tsjekkisk Republikk
- Nemocnice Na Homolka
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
Exclusion Criteria:
- Patient with history of cardiac or pericardial surgery in the past 6 months
- Patient with history of chronic pericarditis
- Myocardial infarction within 4 weeks prior to procedure
- Class IV NYHA (New York Heart Association) heart failure symptoms
- Cerebrovascular accident within previous 6 months
- Known carotid artery stenosis greater than 80%
- Presence of thrombus in the left atrium
- Coagulopathy
- Severe Hepatic Dysfunction or Enlargement
- Life expectancy less than 6 months
- BMI > 40
- Patient is enrolled in another clinical trial
- Patient is pregnant
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: EpiAccess
EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
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Access to the pericardium to enable further treatments.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
Tidsramme: Through discharge / approx 4 days
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EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved.
The percentage of patients in whom pericardial access was successful will be reported.
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Through discharge / approx 4 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
Tidsramme: access through procedure completion
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EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.
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access through procedure completion
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Percentage of Participants With a Pericardial Effusion of >80ml
Tidsramme: Access through discharge/approximately 4 days
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Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.
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Access through discharge/approximately 4 days
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System
Tidsramme: Access through end of procedure
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Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey
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Access through end of procedure
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Andrea Natale, MD, University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DR-002 (rev C)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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