Clinical trials: TAVR
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07100340)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Transcatheter Aortic Valve Replacement
Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement
This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients…
- Trial name
- NCT04107038
- Testing
- General Endotracheal Anesthesia, Monitored anesthesia care
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Transcatheter Aortic Valve Replacement, Aortic Regurgitation
TAVR in Adults With Pure Severe Aortic Regurgitation
The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study.
- Trial name
- SENSE-AR (NCT05737264)
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Aortic Valve Stenosis
The Medtronic TAVR 2.0 US Clinical Study
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk…
- Trial name
- NCT02738853
- Testing
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Where
- 8 sites in United States
- Volunteers
- 93 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study.
The purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.
- Trial name
- DEFINE-TAVR (NCT05567809)
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Yale University
Moderate Aortic Valve Stenosis
POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.
- Trial name
- NCT06650839
- Testing
- NIUT
- Where
- Serbia
- Sponsor
- Cardiawave SA
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 Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement
This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025.
- Trial name
- CHATEAU (NCT07709858)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- South Korea
- Volunteers
- 4,000 people
- Sponsor
- Eunpyeong St. Mary's Hospital
Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk.
- Trial name
- TOGETHER (NCT05711186)
- Testing
- Structured SDM, Usual Care
- Where
- 2 sites in Switzerland
- Volunteers
- 140 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Transcatheter Aortic Valve Replacement
Cara CDRS (Conduction Disturbance Risk Score) 1.0
Prospective, non-randomized, multicenter data collection study. Eligible TAVR patients will be enrolled in the study. Cardiac conduction disturbances (CD) requiring permanent pacemaker implantation (PPM) or causing new-onset CD…
- Trial name
- CDRS (NCT05657912)
- Testing
- ECG monitoring
- Where
- 3 sites in Canada, Italy and 1 more
- Volunteers
- 355 people
- Sponsor
- Cara Medical Ltd
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Transcatheter Aortic Valve Replacement
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).
- Trial name
- GALILEO (NCT02556203)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA), Clopidogrel
- Where
- 140 sites in United States, Austria and 15 more
- Volunteers
- 1,653 people
- Sponsor
- Bayer
Valvular Heart Disease
The PROTEMBO C Trial
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve…
- Trial name
- NCT04618718
- Testing
- cerebral embolic protection during TAVR
- Where
- 8 sites in Germany, Latvia and 1 more
- Volunteers
- 64 people
- Sponsor
- Protembis GmbH
Aortic Stenosis, Severe, Anxiety
Anxiety Reduction in TAVI Using Virtual Reality Trial
The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement…
- Trial name
- ART-VR (NCT05069987)
- Testing
- Virtual Reality Immersion
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Erasmus Medical Center
Severe Aortic Valve Stenosis
The PROTEMBO Trial
The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and…
- Trial name
- NCT05873816
- Testing
- ProtEmbo - Cerebral Embolic Protection, Sentinel - Cerebral Embolic Protection
- Where
- 20 sites in United States, Germany and 1 more
- Volunteers
- 284 people
- Sponsor
- Protembis GmbH
Native and Valve in Valve Aortic Valve Failure
Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation
Background: TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone.
- Trial name
- BASILICA (NCT03381989)
- Testing
- ASHI_INTECC Astato XS 20 0.014 guidewire
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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 Valve Stenosis
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)
Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions.
- Trial name
- NCT05774691
- Testing
- Protamine sulfate
- Where
- 6 sites in Belgium, Netherlands
- Volunteers
- 1,000 people
- Sponsor
- St. Antonius Hospital
Aortic Stenosis Symptomatic
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic…
- Trial name
- NCT06680427
- Testing
- Siegel Transcatheter Aortic Valve (TAVR)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- MiRus