Clinical trials: Valve Replacement
Transcatheter Aortic Valve Replacement
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06871774
- Testing
- Single Perclose Pro vascular closure device, Dual Perclose vascular closure device
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Wake Forest University Health Sciences
Transcatheter Aortic Valve Replacement, Closure Technique
This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement
This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy…
- Trial name
- TAVI-CLOSE (NCT06983938)
- Testing
- Double Perclose Proglide, Single Perclose Proglide plus Angioseal
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Baylor Research Institute
Cardiac Surgery, Peri Operative Medicine
Risk Factors of Atrial Fibrillation After Cardiac Surgery
Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death.
- Conditions
- Cardiac Surgery, Peri Operative Medicine, Thoracic Surgery, Cardiopulmonary Bypass
- Trial name
- PFAS (NCT07625033)
- Where
- France
- Volunteers
- 918 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Transcatheter Aortic Valve Replacement (TAVR), Cerebral Vascular Accident (CVA)/Stroke
Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during…
- Trial name
- NCT07648693
- Testing
- CHORDS® Cerebral Protection System, Sentinel Cerebral Protection System
- Where
- 15 sites in China
- Volunteers
- 240 people
- Sponsor
- Resonova (Shanghai) Medtech Limited
Mitral Insufficiency, Transcatheter Aortic Valve Replacement
Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study
Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases.
- Trial name
- TEMATIC-MR (NCT07370467)
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Centro Cardiologico Monzino
Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis.
- Conditions
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, Colchicine
- Trial name
- Co-STAR (NCT04870424)
- Testing
- Colchicine
- Where
- Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Symptomatic Aortic Stenosis, Aortic Valve Stenosis
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic…
- Conditions
- Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
- Trial name
- SMART (NCT04722250)
- Testing
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems, Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 1,103 people
- Sponsor
- Medtronic Cardiovascular
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients.
- Conditions
- Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
- Trial name
- PROMOTE (NCT04139616)
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Percutaneous Coronary Intervention, Valve Repair/Replacement
Cardiac Rehab Referral Nudges
Investigators will evaluate the effectiveness of two different EHR-embedded nudges to improve referral to cardiac rehabilitation.
- Conditions
- Percutaneous Coronary Intervention, Valve Repair/Replacement, Coronary Artery Bypass Grafting
- Trial name
- NCT07607522
- Testing
- EHR Nudges
- Where
- United States
- Volunteers
- 7,000 people
- Sponsor
- NYU Langone Health
Mitral Valve Replacement
Replacement of the Native Mitral Valve Using the ReValve System
This study is to collect preliminary chronic information on performance and safety of the ReValve System.
- Trial name
- NCT07601269
- Testing
- ReValve System
- Where
- 2 sites in Brazil
- Volunteers
- 25 people
- Sponsor
- ReValve Solutions Inc.
Aortic or Mitral Valve Replacement, Valvular Heart Disease Patients
Association of Prosthesis Types for Aortic or Mitral Valve Replacement With Long-term Risk of Mental Disorders
Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement. The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between…
- Trial name
- NCT07489313
- Volunteers
- 1,811 people
- Sponsor
- Samsung Medical Center
Transcatheter Aortic Valve Replacement, Coronary Artery Disease
Coronary Artery Disease Assessment Strategies in TAVI Patients
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.
- Conditions
- Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
- Trial name
- CAT (NCT06559332)
- Testing
- Risk-based CAD management, Invasive coronary angiography
- Where
- Switzerland
- Volunteers
- 546 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Coronary Arterial Disease (CAD), Valve Replacement
Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
Evacuation of pericardial blood by posterior pericardiotomy or use of a posterior pericardial chest tube lowers postoperative atrial fibrillation (POAF) rates after cardiac surgery by 45-68%.
- Conditions
- Coronary Arterial Disease (CAD), Valve Replacement, Aortic Surgery
- Trial name
- PROPER (NCT06800781)
- Testing
- Prolonged treatment with posterior pericardial chest tube plus standard care
- Where
- Sweden
- Volunteers
- 624 people
- Sponsor
- Region Skane
Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
Patient Quality of Recovery After TAVR With Different Sedation Regimens
The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure.
- Trial name
- NCT07556523
- Testing
- Propofol, Dexmedetomidine, Midazolam
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- David Lyubashevsky
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.
High Degree Second Degree Atrioventricular Block, Complete Heart Block
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure.
- Conditions
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- RAFT-TAVR PACE (NCT06857201)
- Testing
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)
Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role, recent data underline the possibility of a postponed coronary intervention using a commissural alignment technique.
- Trial name
- COMFORT (NCT05779787)
- Testing
- TAVR Aligned, TAVR Random
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Niguarda Hospital
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Ischemic And Bleeding Risk Assessment After TAVR
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).
- Trial name
- FOCUS ONE (NCT06000943)
- Testing
- Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
- Where
- 12 sites in Belgium, Chile and 3 more
- Volunteers
- 2,500 people
- Sponsor
- Niguarda Hospital
AORTIC VALVE DISEASES, Valve-in-valve Procedures
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic…
- Conditions
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement, Valve Disease, Aortic
- Trial name
- REVIVAL (NCT07524595)
- Testing
- Hydra THV Series, Sapien THV Series and MyVal THV Series
- Where
- Ireland
- Volunteers
- 111 people
- Sponsor
- National University of Ireland, Galway, Ireland
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity…
- Trial name
- NCT06420830
- Testing
- SAPIEN 3 Ultra RESILIA Valve
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval