Clinical trials: Cardiac Valve Disease
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
Tricuspid Regurgitation
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation
Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.
- Trial name
- NCT01502462
- Where
- South Korea
- Volunteers
- 131 people
- Sponsor
- Asan Medical Center
Severe Aortic Valve Stenosis
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
- Trial name
- BSC07 (NCT05847751)
- Testing
- Aortic valve replacement
- Where
- 7 sites in Egypt, Lebanon and 1 more
- Volunteers
- 51 people
- Sponsor
- Ceric Sàrl
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Reconstruction
Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy
Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St.
- Trial name
- NCT03818113
- Testing
- cardioplegia with HTK-Bretschneider cardioplegic solution, cardioplegia with St. Thomas cardioplegic solution
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- University Hospital, Basel, Switzerland
Left Bundle-Branch Block, Aortic Stenosis
Study on Heart Block Risks Using Outcome-Based Modeling
This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis…
- Trial name
- SAVIOR (NCT07065123)
- Testing
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Aortic Stenosis
Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement
100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.
- Trial name
- NCT03557242
- Testing
- TAVR, Warfarin plus Aspirin, Aspirin Only
- Where
- 7 sites in United States
- Volunteers
- 124 people
- Sponsor
- Medstar Health Research Institute
Mitral Stenosis
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis.
Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications.
- Trial name
- NCT06340997
- Testing
- Transesophageal echocardiography
- Volunteers
- 25 people
- Sponsor
- Assiut University
Mitral Regurgitation
Outcome Registry and Assessment of New Edge-to-Edge Repair
The goal of this observational study is to learn about the long-term effects of Edge-tot-edge repair of all the patients of AmsterdamUMC, to treat their Mitral regurgitation (MR).
- Trial name
- ORANGE-TEER (NCT07108907)
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Abby Geerlings
Aortic Valve Stenosis, Stroke
Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II
The aim of this study is to assess the possible neuroprotective effects of cooling (targeted cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI) procedures.
- Trial name
- NCT01822964
- Testing
- targeted brain cooling (33°C) by RhinoChill device
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Hasselt University
Mitral Valve Disease
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population.
- Trial name
- NCT05898230
- Testing
- Mitral Valve Replacement
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- Corcym S.r.l
Heart Valve Diseases
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve…
- Trial name
- PAS (NCT01116037)
- Testing
- ATS 3f Aortic Bioprosthesis
- Where
- 6 sites in United States, Canada
- Volunteers
- 26 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Valve Stenosis
Engager Align Post-market Clinical Study
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
- Trial name
- NCT02149654
- Testing
- Engager Transcatheter Aortic Valve Implantation System
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tricuspid Regurgitation, Mechanical Ventilation Pressure High
Effect of PEEP on TRJV in Mechanically Intubated Pediatric Patients
Prospective observational cohort study within the Pediatric Intensive Care Unit (PICU). We will perform point-of-care-ultrasound (POCUS) to quantify tricuspid regurgitant jet velocity (TRJV) on mechanically ventilated (MV)…
- Conditions
- Tricuspid Regurgitation, Mechanical Ventilation Pressure High, Pediatric Respiratory Diseases
- Trial name
- NCT06229886
- Testing
- Application of positive-end-expiratory pressure
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Eisenmenger Syndrome
Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
A growing body of data, suggests that transcatheter valves are effective when implanted in other locations (mitral, aortic, tricuspid) and in high pressure environments.
- Trial name
- NCT02119442
- Testing
- Transcather Valve Implantation
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University of California, Los Angeles
Hypertrophic Cardiomyopathy (HCM)
ReGistry of hypeRtrophic cArDIomyopathy: Regional fEatures, geNeTics and Course
This study is envisioned as the very first of its kind in the Russian Federation, aiming to provide a comprehensive characterization of the clinical spectrum and disease burden, focusing on the epidemiology and progression of HCM…
- Trial name
- GRADIENT (NCT07295613)
- Where
- 2 sites in Russia
- Volunteers
- 1,400 people
- Sponsor
- Central State Medical Academy
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
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
Mitral Stenosis
Assessment of Right Ventricular Function in Patients With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty
To detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function
- Trial name
- NCT06067815
- Volunteers
- 30 people
- Sponsor
- Assiut University