Clinical trials: TAVI
Aortic Valve Stenosis
Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.
- Trial name
- SAFETAVR (NCT03600935)
- Testing
- Vancouver Clinical Pathway
- Volunteers
- 315 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Aortic Valve Disease, Aortic Valve Insufficiency
J-Valve TF Early Feasibility Study
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to…
- Conditions
- Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation
- Trial name
- JVTF EFS (NCT06034028)
- Testing
- J-Valve TF System
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Aortic Stenosis Disease
Aortic Stenosis - Prognosis, Risk and Outcomes
The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden.
- Trial name
- MASTER (NCT06863883)
- Where
- 2 sites in Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy…
- Trial name
- CT-CA (NCT03291925)
- Testing
- Selective invasive angiography based on CT/CCTA imaging., Procedure/Surgery: Invasive angiography
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement System Pivotal Trial
Prospective, randomized, unblinded, multi-center investigational study with enrollment at up to 45 investigational sites. The study is designed to compare the study device (Direct Flow Medical Transcatheter Aortic Valve System)…
- Trial name
- SALUS (NCT02163850)
- Testing
- Direct Flow Medical, Commercially Available
- Where
- 3 sites in United States
- Volunteers
- 878 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis
Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.
Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate.
- Trial name
- NCT01237743
- Testing
- Transcatheter aortic valve implantation.
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Sahlgrenska University Hospital
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the Hamilton General Hospital.
- Trial name
- NCT06040398
- Testing
- JUMPSTART exercise program
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Hamilton Health Sciences Corporation
Transcatheter Aortic Valve Implantation
Registry of Aortic Valve Bioprostheses Established by Catheter
The aim of this registry is to evaluate the overall survival up to 10 years of patients with aortic valve bioprostheses implanted via the transarterial or transapical route.
- Trial name
- FRANCE-TAVI (NCT01777828)
- Where
- France
- Volunteers
- 5,000 people
- Sponsor
- French Cardiology Society
Aortic Valve Disease
Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes
Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation…
- Trial name
- NCT05389631
- Testing
- no intervention
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Helios Health Institute GmbH
Aortic Valve Disease, Chronic Kidney Disease
Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement
Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy, Acute Kidney Injury
- Trial name
- PANTER (NCT03121053)
- Testing
- sodium bicarbonate, hypotone saline
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- St. Antonius Hospital
TAVI(Transcatheter Aortic Valve Implantation), TAVI
Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), TAVI, Quality of Life, Mental Health
- Trial name
- QualiTAVI-UK (NCT07193004)
- Testing
- Quality of Life
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- University Hospital Plymouth NHS Trust
Patients Above 18 Years, Patient Discharge
One Year Pacing Dependency After TAVR
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and…
- Conditions
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Trial name
- PACETAVI (NCT06756282)
- Testing
- Pacemaker and defibrillator
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Montpellier
Transcatheter Aortic Valve Replacement
Prognostic Factors in NOP-LBBB After TAVI
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI).
- Trial name
- ProgNOP-LBBB (NCT05654792)
- Testing
- Transcatheter aortic valve implantation
- Volunteers
- 230 people
- Sponsor
- Central Hospital, Nancy, France
TAVI
Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
- Trial name
- NCT04083040
- Testing
- transcatheter aortic valve implantation
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Assiut University
Severe Aortic Valve Stenosis
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
- Trial name
- NCT04988243
- Testing
- All aortic valve products on the market
- Volunteers
- 320 people
- Sponsor
- CCRF Inc., Beijing, China
Aortic Stenosis, Mitral Regurgitation
Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
an international multicentre registry designed to answer 3 clinical questions: 1. Describing the characteristics and outcomes of current patients undergoing aortic + mitral transcatheter heart valve procedures. 2.
- Trial name
- AMTRAC (NCT04031274)
- Testing
- TAVI, TMVR/r
- Where
- Israel
- Volunteers
- 10,000 people
- Sponsor
- Rabin Medical Center
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis…
- Trial name
- TAVI (NCT03633383)
- Testing
- Transcatheter aortic valve
- Volunteers
- 50 people
- Sponsor
- Assiut University
Aortic Valve Stenosis
Vascular Closure Device in Transcatheter Aortic Valve Replacement
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a…
- Trial name
- NCT04392492
- Testing
- MANTA vascular closure device
- Where
- Sweden
- Volunteers
- 1,000 people
- Sponsor
- Karolinska University Hospital
Severe Aortic Valve Stenosis, High-degree AV Block
Infranodal Conduction Time During TAVR as Predictor of HAVB
Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker…
- Conditions
- Severe Aortic Valve Stenosis, High-degree AV Block, Left Bundle-Branch Block
- Trial name
- HOM-TAVI (NCT04128384)
- Testing
- Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University Hospital, Saarland