Clinical trials: Aortic Valve Replacement
Aortic Stenosis
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.
- Trial name
- NCT06472934
- Testing
- Transcatheter aortic valve replacement in the absence of B-blocker treatment, Transcatheter aortic valve replacement
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 498 people
- Sponsor
- University Hospital, Basel, Switzerland
Aortic Stenosis
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
- Trial name
- TAVR-CMR (NCT03831087)
- Testing
- TAVR-CMR, TAVR-CT
- Where
- Austria
- Volunteers
- 267 people
- Sponsor
- Medical University Innsbruck
Cerebral Embolicprotection Device, TAVR
Cerebral Embolic Protection Device During TAVR
To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve…
- Trial name
- NCT07627984
- Testing
- Cerebral embolic protection device
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
ATTR Amyloidosis Wild Type, Severe Aortic Stenosis
Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR
ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known.
- Conditions
- ATTR Amyloidosis Wild Type, Severe Aortic Stenosis, Aortic Valve Stenosis, Middle East Studies
- Trial name
- NCT06015997
- Volunteers
- 100 people
- Sponsor
- Jordan Collaborating Cardiology Group
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
The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery
This study is looking at the effects of high spinal anesthesia (also known as total spinal anesthesia) combined with general anesthesia versus general anesthesia alone on the following: Stress response: Patients undergoing aortic…
- Trial name
- NCT00348920
- Testing
- High Spinal and General Anesthesia
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- University of Manitoba
Systemic Inflammatory Response, Aortic Valve Stenosis
Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement
Aim of this randomized prospective study is to investigate the immunomodulatory effects of dexmedetomidine on outcomes in patients with isolated aortic stenosis after surgical aortic valve replacement.
- Trial name
- NCT05641064
- Testing
- Dexmedetomidine 0.5mcg/kg/h, Dexmedetomidine 1 mcg/kg/h
- Where
- Croatia
- Volunteers
- 60 people
- Sponsor
- University Hospital Dubrava
Heart Valve Diseases
Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a…
- Trial name
- NCT00221663
- Testing
- surgery techniques (sternotomy for aortic valve replacement)
- Where
- France
- Volunteers
- 78 people
- Sponsor
- University Hospital, Bordeaux
Transcatheter Aortic Valve Replacement, Conduction Disturbance
Intra-procedural ECG Changes During TAVR
The purpose of this study is to evaluate electrocardiogram (ECG) changes in 100 patients undergoing transcatheter aortic valve replacement (TAVR) to assess new-onset conduction abnormalities, such as atrioventricular nodal block…
- Trial name
- NCT05791344
- Testing
- ECG monitoring
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Cara Medical Ltd
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR)
Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction.
- Conditions
- Left Ventricle Function, Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
- Trial name
- TRANSLATE (NCT07455292)
- Testing
- Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement
- Where
- 2 sites in Italy
- Volunteers
- 190 people
- Sponsor
- IRCCS Policlinico S. Donato
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 Stenosis, Brain Infarction
Neuroprotection in Patients Undergoing Aortic Valve Replacement
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
- Conditions
- Aortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke
- Trial name
- NCT02389894
- Testing
- Embol-X Embolic Protection Device, CardioGard Cannula
- Where
- 18 sites in United States, Canada
- Volunteers
- 383 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Aortic Stenosis
Avr Thrombosis OutcoMe Study
This study aims to utilise novel biomarkers assessing thrombosis and thrombolysis (through a blood test), to identify patients undergoing either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation…
- Trial name
- ATOM (NCT04234841)
- Testing
- Blood test
- Where
- United Kingdom
- Volunteers
- 750 people
- Sponsor
- East and North Hertfordshire NHS Trust
Bradycardia
Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation.
- Trial name
- NCT03180073
- Testing
- Ziopatch Pre discharge, Ziopatch at Discharge, Ziopatch at 2 months
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Infective Endocarditis, Heart Failure
Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft
: Evidence suggested that autologous or allogeneic tissue is more suitable to synthetic material in an infected field. Given the unwillingness of some surgeons to use artificial foreign materials, such as conventional mechanical…
- Trial name
- IESCOPHO (NCT05253469)
- Testing
- Cryopreserved Aortic Homograft, Stented/Non stented xenograft, Mechanical prostheses
- Where
- France
- Volunteers
- 760 people
- Sponsor
- Centre Cardiologique du Nord
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Aortic Valve Stenosis, Heart Valve Diseases
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)
Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female…
- Trial name
- RHEIA (NCT04160130)
- Testing
- Transcatheter aortic valve replacement
- Where
- 48 sites in Austria, Belgium and 10 more
- Volunteers
- 432 people
- Sponsor
- Optimapharm