The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device. The study will be conducted to evaluate the device design concept with respect to clinical safety and device functionality.
The patient is ≥18 years of age;
The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
The patient is willing to comply with protocol-specified follow-up evaluations;
The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.
TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
Anatomy that precludes safe delivery and retrieval of the investigational device.
Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
Transverse Medical, Inc.
Lead sponsor
Medical Metrics Diagnostics, Inc
Collaborator
Monash Health
Collaborator
Transverse Medical Australia
Collaborator
Ascend Clinical
Collaborator