Clinical trials: Transcatheter Valve Replacement
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
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 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 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
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
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
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 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
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 40 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
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
Aortic Stenosis
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral…
- Trial name
- NCT02786264
- Testing
- Dexmedetomidine with propofol, Propofol
- Volunteers
- 186 people
- Sponsor
- Yale University
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
Aortic Stenosis, Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
This is a prospective observational study, the purpose of which is to: 1. Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, Heart Block
- Trial name
- TAVR-HBE (NCT04982406)
- Testing
- Transcatheter aortic valve replacement
- Where
- United States
- Volunteers
- 409 people
- Sponsor
- Beth Israel Deaconess Medical Center
Heart Block, Aortic Stenosis
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in…
- Conditions
- Heart Block, Aortic Stenosis, Bundle-Branch Block
- Trial name
- GLUCO-TAVR (NCT06076824)
- Testing
- Methylprednisolone
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital General Universitario de Alicante
Aortic Valve Stenosis
TranScatheter Aortic Valve RepLacement System US Feasibility Trial
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair.
- Trial name
- SALUS (NCT01932099)
- Testing
- Transcatheter aortic valve replacement
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis
Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.
- Trial name
- NCT03557242
- Testing
- TAVR, Warfarin plus Aspirin, Aspirin Only
- Where
- 7 sites in United States
- Volunteers
- 124 people
- Sponsor
- Medstar Health Research Institute