Clinical Trials Logo
  1. Home
  2. Severe Aortic Stenosis
  3. NCT04076150

Safety and Performance Study of the Optimum Transcatheter Aortic Valve

Severe Aortic Stenosis Clinical Trial

Official title:
A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant

Clinical Trial Summary

The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant

Clinical Trial Description

The purpose of the study is to assess the safety and performance of the Optimum TAV (Transcatheter Aortic Valve) in patients with symptomatic, severe aortic stenosis who are deemed high-risk for SAVR (Surgical Aortic Valve Replacement) or have contraindications or deemed inoperable for SAVR. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04076150
Study type Interventional
Source Thubrikar Aortic Valve, Inc.
Contact Mano Thubrikar, PhD
Phone 6106308284
Email mano.thubrikar@tavi.us
Status Recruiting
Phase N/A
Start date May 18, 2022
Completion date May 18, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT01238497 - SOURCE XT REGISTRY
Recruiting NCT04029844 - Colibri Transcatheter Aortic Heart Valve System Study N/A
Recruiting NCT03280433 - Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study N/A
Completed NCT05492383 - SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) N/A
Active, not recruiting NCT03752866 - The CONFIDENCE Registry N/A
Completed NCT01651780 - Open-label, Randomized Trial in Patients Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH Phase 3
Recruiting NCT06173115 - Comparison of a Single Versus Double Perclose Technique for TAVR N/A
Recruiting NCT06136429 - A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis N/A
Not yet recruiting NCT06015997 - Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR
Recruiting NCT03291925 - Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI N/A
Terminated NCT03004599 - Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis N/A
Completed NCT01074658 - CoreValve Advance International Post Market Study N/A
Completed NCT02575768 - Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease N/A
Completed NCT01994330 - Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement Surgery Phase 4
Completed NCT04286893 - Improved HRV, Inflammation Markers and Endothelial Function After TAVI
Not yet recruiting NCT06177392 - VARC-TAVI VALVE IMPLANTATION) N/A
Active, not recruiting NCT04206228 - Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis Phase 2
Not yet recruiting NCT03788590 - Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System N/A
Completed NCT01531374 - Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement N/A
Recruiting NCT05493657 - Aspirin vs Clopidogrel After TAVR N/A