"EASE" Epicardial Access With the EpiAccess System (EASE2)
EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
Studie Overzicht
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Prague, Tsjechische Republiek
- Nemocnice Na Homolka
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Andrea Natale, MD, University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DR-002 (rev C)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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