Aortic Valve Stenosis Clinical Trial
Official title:
Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care
The study is an open-label observational study involving a minimum of 10 centers. A minimum
of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV)
treatment patients, will be enrolled. Enrollment will continue until all 3 of these
conditions are met.
BAV-only patients will be followed through a 6-month post-treatment telephone follow up.
Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve
replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural
predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or
at 6 months post-BAV treatment, whichever comes first.
;
Observational Model: Case-Only, Time Perspective: Prospective
| 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| Withdrawn |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 |
NCT02758964 -
Evaluation of Cerebral Thrombembolism After TAVR
|
||
| Completed |
NCT02792452 -
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
|
||
| Completed |
NCT02847546 -
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
|
N/A | |
| 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
|