A prospective, non-randomized, multi-center, open-label clinical investigation to assess the safety and technical performance of the Emboliner embolic protection catheter.

Not Applicable

Completed

• Conditions: transcatheter aortic valve replacement; embolic protection; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12619000179134
• Lead Sponsor: Emboline, Inc.

Brief Summary

1. Research Question The primary purpose of the SafePass 2 evaluation was to evaluate the safety and technical feasibility of the Emboliner™ embolic protection catheter. 2. Background Information SafePass 2 was a safety and feasibility study of the Generation 2 Emboliner™ during Transcatheter Aortic Valve Replacement (TAVR). Cerebral embolism is a known complication of cardiac surgery. Embolic particles, which may include thrombi, valvular tissue, and foreign material, may become dislodged by surgical or catheter manipulations and enter the bloodstream which can lead to neurological and neurocognitive deficits, stroke, or death. The Emboliner™ embolic protection catheter provides embolic protection during interventional cardiology procedures, such as transcatheter aortic valve replacement (TAVR). 3. Participant Characteristics Thirty-one (31) patients with severe aortic stenosis were enrolled. Subjects enrolled ranged in age from 65 to 92, with an average age of 79. 4. Key Results Thirty-one (31) subjects were enrolled into the SafePass 2 study at three (3) sites in New Zealand, from April 2019 to November 2019. Two (2) of the thirty-one (31) subjects (6%) experienced a MACCE (defined as: death, stroke, or Stage 3 acute kidney injury). Both events had no causal relationship to the Emboliner™ system, as determined by the Investigator. Of the thirty-one (31) subjects, full technical success was met in all cases (100%). The Emboliner™ is technically feasible for use.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-07
• Study Completion: 2019-11-04
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1.The patient must be 18 years and older
2.The patient must be a candidate for TAVR according
3.The patient has been provided written informed consent

Exclusion Criteria

1.Patients with an ascending aortic diameter [that meets the requirements of product labeling]
2.Patients with the linear distance from the femoral access site to the aortic valve root [per product labeling]
3.Patients not undergoing TAVR via the trans-femoral route.
4.Patients that are contraindicated for anticoagulant and/or antiplatelet therapy or uncorrected bleeding disorder.
5. Pregnant or nursing subjects, or subjects who intend to become pregnant during the term of the study.
6. Patients with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure.
7. Patients with known other mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year.
8. Patients with severe allergy to study materials or required medication that cannot be adequately pre-medicated or adequately controlled.
9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
10. Patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months.
11. Patients with renal failure.
12. Patients presenting with cardiogenic shock or severe hypotension.
13. Patients with severe peripheral arterial disease that precludes delivery sheath vascular access, or whose vascular anatomy is unable to accommodate the access sheath.
14. Patients who have a planned treatment with any other investigational device or procedure during the study period.
15. Patients planned to undergo any other cardiac surgical or interventional procedure within two (2) weeks prior to the TAVR procedure, or 30 days after the TAVR procedure.
16. Patients with aortic implant or other abnormality (e.g., asymmetrical or sharp aortic calcifications).
17. Emergency patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified