We Are Currently Enrolling in This Study.
Feasibility Protocol for Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients with Infective Endocarditis
About the PAVE Study
- The PAVE study is sponsored by AngioDynamics, Inc., developer of the AngioVac System.
- The PAVE study is a prospective, multicenter, single-arm feasibility study that will enroll up to 30 patients with confirmed right-sided infective endocarditis (RSIE).
- The PAVE study will evaluate initial safety and effectiveness of the AngioVac Cannula for the removal of vegetation from the right heart.
- The primary effectiveness endpoint of the PAVE study is a composite of 30-day survival, absence of persistent bacteremia within 30 days post-procedure, and absence of further right-sided valve intervention through 30 days post-procedure.
- The primary safety endpoint is the rate of Major Adverse Events within 48 hours post-procedure, including all-cause mortality, major bleeding, and device- or procedure-related adverse events of cardiac perforation, vascular perforation, dissection, or pericardial effusion/tamponade.
- Patients will have follow-up visits at 1 day, 7 days, 30 days, and 6-month post-procedure.
Risk Statement: Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.
CAUTION: The use of the AngioVac System for the removal of vegetations from the right side of the heart is an investigational device limited by United States law for investigational use only.
Federal law (USA) restricts this device to sale by or on the order of a physician
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