Aortic Valve Stenosis Clinical Trial
Official title:
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following Medtronic CoreValve or Other Self-Expanding TAVI Procedure (PostCorE)
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and is being investigated for an expanded intended use.
The study is a prospective, multi-center, single arm open-label clinical study involving up
to 5 centers and a minimum of 20 subjects. Up to 50 subjects may be enrolled in this study.
The first 3 post-dilatation procedures for each investigator will be considered roll-ins and
not included in the main study analyses. Subjects will exit the study at hospital discharge
or 7 days post treatment, whichever comes first. The expected duration of the clinical
investigation is approximately 6 months.
Subjects implanted with the CoreValve or other commercially available self-expanding TAVI
and with the use of the V8 as a postdilatation balloon may be enrolled in this study. The
subject will exit the study after the predischarge ECHO where the Paravalvular Leak (PVL)
measurements are taken or resolution of a V8 related AE (if applicable).
;
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| Withdrawn |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 |
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
|