Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure
Not Applicable
Completed
- Conditions
- Venous Puncture
- Registration Number
- NCT04831008
- Lead Sponsor
- Delray Medical Center
- Brief Summary
The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.
- Detailed Description
Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.
Exclusion Criteria
- Patients who do not consent
- Minors or those unable to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Procedure Time Immediate Access Site Complication 1 month Hemostasis Time Immediate To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Delray Medical Center🇺🇸Delray Beach, Florida, United States