Clinical trials: TAVI
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis, Aortic Stenosis With Bicuspid Valve
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic…
- Trial name
- NCT04722796
- Testing
- TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution), TAVR with Venus A plus using annular sizing and THV implantation technique
- Where
- 18 sites in China
- Volunteers
- 508 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Acute Kidney Injury
Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation
Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI).
- Trial name
- NCT04537325
- Testing
- RenalGuard system
- Where
- Germany
- Volunteers
- 98 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Stenosis
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
- Trial name
- RADIANT (NCT02799823)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- HLT Inc.
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07100340)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Aortic Valve Stenosis
The Prospective Segeberg TAVI Registry
A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany
- Trial name
- POST-TAVI (NCT03192774)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- Segeberger Kliniken GmbH
Left Ventricular Systolic Function
Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR
- Trial name
- NCT05069168
- Testing
- Echocardiography before and after TAVR
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Assiut University
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Ischemic And Bleeding Risk Assessment After TAVR
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).
- Trial name
- FOCUS ONE (NCT06000943)
- Testing
- Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
- Where
- 12 sites in Belgium, Chile and 3 more
- Volunteers
- 2,500 people
- Sponsor
- Niguarda Hospital
Aortic Stenosis
TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with…
- Trial name
- NOSCAR-TAVI (NCT07515768)
- Testing
- transcathter aortic valve implantation
- Volunteers
- 404 people
- Sponsor
- Medical University of Warsaw
Transcatheter Aortic Valve Replacement
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06871774
- Testing
- Single Perclose Pro vascular closure device, Dual Perclose vascular closure device
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Aortic Valve Stenosis, Pulmonary Hypertension
Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population.
- Trial name
- HTP-TAVI (NCT04008550)
- Testing
- Right Heart Catheterization
- Where
- France
- Volunteers
- 101 people
- Sponsor
- University Hospital, Rouen
Aortic Stenosis
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.
- Trial name
- NCT06472934
- Testing
- Transcatheter aortic valve replacement in the absence of B-blocker treatment, Transcatheter aortic valve replacement
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 498 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Valve Stenosis, Cardiovascular Diseases
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid
- Trial name
- Bicuspid TAVR (NCT02394184)
- Testing
- transcatheter aortic valve replacement
- Where
- South Korea
- Volunteers
- 102 people
- Sponsor
- Seung-Jung Park
Transcatheter Aortic Valve Replacement
The CAPTIS® Study - Embolic Protection in TAVR
This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT04659538
- Testing
- CAPTIS Embolic Protection device
- Where
- 3 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Filterlex Medical Ltd.
Aortic Valve Stenosis
ASAN Medical Center Aortic Valve Replacement Registry
This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.
- Trial name
- ASAN-AVR (NCT03298178)
- Testing
- TAVR, SAVR
- Where
- South Korea
- Volunteers
- 900 people
- Sponsor
- Ho-Jin Kim
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
Transcatheter Aortic Valve Replacement
Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural).
- Trial name
- BIO TAVI (NCT02812953)
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Action, France