Clinical trials: Transcatheter Aortic Valve Replacement (TAVR)
Atrial Fibrillation
Pharmacological Intervention to Prevent NOAF After TAVR
The goal of this clinical trial is to learn if amiodarone or metoprolol works to prevent new-onset atrial fibrillation (AF) in patients who develop certain atrial arrhythmias after transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT07519161
- Testing
- Metoprolol succinate, Amiodarone
- Volunteers
- 198 people
- Sponsor
- Shanghai East Hospital
Stroke
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
- Trial name
- PROTECTED TAVR (NCT04149535)
- Testing
- Sentinel® Cerebral Protection System
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
- Trial name
- NCT03004599
- Testing
- SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Medico's Hirata Inc.
Aortic Stenosis, Aortic Valve Stenosis
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics)…
- Trial name
- NCT04827238
- Testing
- Standardized Invasive Hemodynamics
- Where
- 9 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- University of British Columbia
Aortic Stenosis, Severe
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT04944667
- Testing
- TAVR planning
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Centro Medico Teknon
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Transcatheter Aortic Valve Implantation
Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a…
- Trial name
- PTOTtAVR (NCT03117296)
- Testing
- Post procedure daily PT and OT, PT post procedure, OT post procedure
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- Henry Ford Health System
Aortic Stenosis, Severe
China S3 PMS: SAPIEN 3 China Post Market Registry Study
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
- Trial name
- NCT05168826
- Testing
- SAPIEN 3 Transcatheter Heart Valve
- Where
- 14 sites in China
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV System: EMBARK Study
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT05182307
- Testing
- DurAVR™ THV System
- Where
- Georgia
- Volunteers
- 150 people
- Sponsor
- Anteris Technologies Ltd.
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
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
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
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, 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
Transcatheter Aortic Valve Replacemen, Echocardiography
Echocardiography Guided TAVR (Echo TAVR)
Conventional transcatheter aortic valve replacement (TAVR) relies on fluoroscopic and contrast agents. However, in high-risk patients, exposure to ionizing radiation and contrast agents is contraindicated and undesirable.
- Trial name
- NCT07030062
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Pan Xiangbin
Aortic Valve Stenosis
The Multidisciplinary, Multimodality, But Minimalist Approach to 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 balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low…
- Trial name
- 3MTAVR (NCT02287662)
- Testing
- Vancouver 3M Clinical Pathway
- Where
- Canada
- Volunteers
- 411 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Aortic Stenosis, Severe
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Trial name
- NCT05172960
- Testing
- SAPIEN X4 THV, SAPIEN X4S
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 1,234 people
- Sponsor
- Edwards Lifesciences