Venus-Vitae Pivotal Study Smart-Align Study

Status Not yet recruiting

Clinical Trial Summary

The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.

Clinical Trial Description

This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05991271
Study type	Interventional
Source	Venus MedTech (HangZhou) Inc.
Contact
Status	Not yet recruiting
Phase	N/A
Start date	October 31, 2023
Completion date	June 30, 2029

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03186339` - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting	`NCT03549559` - Imaging Histone Deacetylase in the Heart	N/A
Terminated	`NCT02854319` - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System	N/A
Recruiting	`NCT05601453` - The ReTAVI Prospective Observational Registry
Withdrawn	`NCT05481814` - CPX in Paradoxical Low Flow Aortic Stenosis
Completed	`NCT02241109` - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity	N/A
Completed	`NCT01700439` - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve	N/A
Recruiting	`NCT04429035` - SLOW-Slower Progress of caLcificatiOn With Vitamin K2	N/A
Completed	`NCT04103931` - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis	N/A
Completed	`NCT03950440` - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting	`NCT02661451` - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)	N/A
Completed	`NCT02847546` - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation	N/A
Completed	`NCT02792452` - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed	`NCT02758964` - Evaluation of Cerebral Thrombembolism After TAVR
Not yet recruiting	`NCT02541877` - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve	Phase 3
Not yet recruiting	`NCT02536703` - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population	Phase 3
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Completed	`NCT02249000` - BIOVALVE - I / II Clincial Investigation	N/A
Active, not recruiting	`NCT02080299` - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation	Phase 2
Terminated	`NCT01939678` - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease