Aandoeningen aan de hartklep Cardiac disease
Conditions
Interventions
In stead of conventional closure techniques, the MANTA 14F or 18F is used
(dependent on size of sheath used, determination of physician).
Sponsors
Essential Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Candidate for non-emergent transcatheter interventional procedure via a 10-18F femoral sheath (e.g., transcatheter aortic valve replacement [TAVR], balloon aortic valvuloplasty [BAV], abdominal aortic aneurysm [AAA] stent-graft placement) * Eligible for sheath removal in the catheterization lab * Age *18 years * Understand and sign the study specific written informed consent form * Able and willing to fulfill the follow-up requirements * In the Investigator*s opinion, the patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial * Patients of childbearing age with Negative Pregnancy Test within 7 days of procedure
Exclusion criteria
Exclusion criteria: Baseline exclusions: * Patients who are known to be pregnant or lactating * Patients who are immunocompromised or with pre-existing autoimmune disease * Patients who have a systemic infection or a local infection at or near the access site * Patients requiring a re-puncture at a site previously punctured within 48 hours * Patients with significant anemia (hemoglobin 40 or 180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure * Patients who are currently participating in another clinical trial of an investigational device or drug that has not concluded the follow-up period * Patients in whom an antegrade puncture is performed or planned * Patients with a known bleeding disorder including thrombocytopenia (platelet count 2,5mg/dl) * Patients undergoing therapeutic thrombolysis * Patients who are unable to ambulate at baseline (necessary to determine time-to-ambulation) * Patients undergoing an interventional procedure whom are being treated with warfarin * Patients requiring a continuous oral anticoagulation therapy or patients with INR >1.8. Patients may be admitted into the study if oral anticoagulation therapy is stopped prior to procedure and resumed after the procedure.;Intra-procedure exclusions: * Patients with puncture sites believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries * Femoral arteries that are suspected to have experienced a back wall puncture or that underwent > one (1) arterial puncture during the catheterization procedure * Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed * Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection * Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula * Patients whose ACT is >250 seconds prior to removal of the guiding catheter * Patients with marked turtuosity of the femoral or iliac artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: The rate of Major Complications, composite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring blood transfusion or vascular repair * Vascular injury requiring repair (e.g. perforation dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm) * Femoral artery stenosis at the access site requiring intervention * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair * Permanent access site-related nerve injury (lasting>30 days) . Primary Effectiveness Endpoint: The rate of Hemostasis Success | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety Endpoint: The rate of Minor Complications within 30±7 days following the procedure, composite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring > 30 minutes to achieve hemostasis * Access site-related hematoma > 6 cm * Late access site-related bleeding (following hospital discharge) * Ipsilateral lower extremity arterial emboli * Ipsilateral deep vein thrombosis * Access site-related vessel laceration * Access site wound dehiscence * Localized access site infection treated with intramuscular or oral antibiotics * Arteriovenous fistula not requiring treatment * Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection * Pseudoaneurysm not requiring treatment * New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair * Ipsilateral pedal pulse diminished by two grades or transiently lost * Any other adverse event that is definitely or probably device-related or access-site related Secondary Effectiveness Endpoints: Time to Hemostasis (The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma)), Time to Ambulation (The elapsed time between MANTA deployment (withdrawal of sheath from artery) and when ambulation is achieved (patient standing and walking at least 20 feet without re-bleeding)) and Treatment Success (MANTA delivery system successfully deployed and hemostasis achieved by MANTA alone or with adjunctive compression (manual or mechanical) with freedom from Major Complications). | — |
Countries
Netherlands
Outcome results
None listed