Clinical trials: TAVR
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 Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
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
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
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.
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
Aortic Valve Stenosis
The Asian Pacific TAVR Multicenter Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population
- Trial name
- AP TAVR (NCT02195102)
- Testing
- Transcatheter aortic valve Replacement
- Where
- 10 sites in China, Japan and 6 more
- Volunteers
- 2,000 people
- Sponsor
- Michael Kang-Yin Lee, MD
Infective Endocarditis of Aortic Valve
Infective Endocarditis After TAVR
This study aims at studying the frequency of infective endocarditis after transcatheter aortic valve replacement/implantation
- Trial name
- INTENSE (NCT03768180)
- Where
- Sweden
- Volunteers
- 4,600 people
- Sponsor
- Region Skane
Anesthesia, Local
Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study)
The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI
- Trial name
- NCT06362915
- Testing
- Lidocaine, Bupivacain
- Where
- 2 sites in Egypt
- Volunteers
- 52 people
- Sponsor
- Ain Shams University
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
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals.
- Trial name
- NCT04810195
- Testing
- Boston Scientific Acurate neo2 TAVR device
- Where
- 4 sites in Denmark, Germany and 1 more
- Volunteers
- 554 people
- Sponsor
- Andreas Rück
Aortic Stenosis, Coronary Artery Disease
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
With the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate.
- Trial name
- RE-ACCESS (NCT04026204)
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Catania
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Structural Valve Deterioration
Single Perclose Escalation Technique for Vascular Closure in TAVR
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end…
- Conditions
- Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration
- Trial name
- NCT05836311
- Testing
- One Perclose Proglide Suture, Two Perclose Proglide Suture
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
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
Cardiac Valve Disease, Aortic Valve Stenosis
Remote ECG Monitoring of TAVI Patients
After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation.
- Trial name
- NCT03810820
- Testing
- mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
- Where
- Canada
- Volunteers
- 240 people
- Sponsor
- Population Health Research Institute
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 Stenosis
Transaxillary TAVR With Solely Echocardiography Guidance
This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS).
- Trial name
- NCT07035847
- Testing
- Echocardiography guided TAVR
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai 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
Valve Disease, Aortic
ArcFlex Sheath in TAVR Trial
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the…
- Trial name
- Arc-FIT (NCT07320274)
- Testing
- ArcFlex Sheath, ordinary sheath
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sun Yat-sen University