Clinical trials: TAVR
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.
Iliac Disease, Aortic Valve Stenosis
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic…
- Trial name
- ILIT (NCT05862558)
- Testing
- Shockwave Balloon
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Baylor Research Institute
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
Transcatheter Aortic Valve Replacement
Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)
Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose…
- Trial name
- NCT05637983
- Testing
- US-guided femoral puncture vs Fluoroscopy-guided puncture
- Where
- Italy
- Volunteers
- 508 people
- Sponsor
- Fondazione Toscana Gabriele Monasterio
Aortic Valve Regurgitation
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation.
- Trial name
- NCT06381271
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xijing Hospital
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center
PM Implantation After TAVR
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Hypothesis of the study is that a modified and improved implantation protocol (regarding membranous septum length and implantation depth) will decrease the need for permanent pacemaker stimulation follow TAVR-procedures.
- Trial name
- MIDAS - ULM (NCT04734392)
- Testing
- TAVR
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University of Ulm
Aortic Valve Stenosis, Aortic Valve Disease
CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation
This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter…
- Trial name
- NCT07008911
- Testing
- CardioHeartConnect, CardioHeartEd
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Colorado, Denver
Moderate Aortic Valve Stenosis
Evolut™ EXPAND TAVR II Pivotal Trial
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
- Trial name
- NCT05149755
- Testing
- Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
- Where
- 94 sites in United States, Australia and 14 more
- Volunteers
- 650 people
- Sponsor
- Medtronic Cardiovascular
Severe Symptomatic Aortic Stenosis
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have…
- Trial name
- Inop AA (NCT01787084)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve
- Volunteers
- 8 people
- Sponsor
- The Society of Thoracic Surgeons
Right Ventricular Dysfunction
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve…
- Trial name
- NCT05804240
- Testing
- 3D TEE RVEF
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Thomas Jefferson University
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
Aortic Stenosis
General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach.
- Trial name
- GALATTAVI (NCT06870734)
- Volunteers
- 44 people
- Sponsor
- University Hospital, Caen
Aortic Stenosis
TAVR Without Predilatation
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon…
- Trial name
- TAVIWOP (NCT04350658)
- Testing
- Transcatheter aortic valve implantation required for symptomatic aortic stenosis
- Where
- France
- Volunteers
- 138 people
- Sponsor
- University Hospital, Montpellier
Transcatheter Aortic Valve Replacement (TAVR)
EasyCrossTM Device-Self-centering Catheter
VIVHEART EasyCross™ is a self-centering device for inserting a guidewire through a heart valve. It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms…
- Trial name
- VIV-FIH (NCT06412354)
- Testing
- EasyCross™ first-in human
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Vivheart s.r.l.
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Aortic Stenosis, Gender
TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over…
- Conditions
- Aortic Stenosis, Gender, Surgery
- Trial name
- NCT04915976
- Volunteers
- 14,086 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
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
Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries. The main questions it aims to answer are: 1.
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment
- Trial name
- NCT06896227
- Testing
- transthoracic echocardiography
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Aortic Valve Disease
TAVR for Aortic Valve Disease
Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement…
- Trial name
- NCT05439863
- Testing
- transcatheter heart valve
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University