Clinical trials: Valve Disease, Heart
Aortic Valve Stenosis, Heart Valve Diseases
Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease
- Trial name
- QUALITY-AVR (NCT02726087)
- Testing
- ministernotomy, Full sternotomy
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Valvular Heart Disease
Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality.
- Trial name
- NCT01825720
- Testing
- (Glucose-Insulin-Potassium)GIK group, normal saline group
- Where
- South Korea
- Volunteers
- 106 people
- Sponsor
- Yonsei University
Mitral Regurgitation, Mitral Valve Disease
CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR).
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Annular Calcification
- Trial name
- CHOICE-MI (NCT04688190)
- Where
- 43 sites in United States, Australia and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Obesity, Spinal Surgery
Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound
Transoesophageal ultrasound examination before and after prone position.
- Conditions
- Obesity, Spinal Surgery, Anaesthesia, Changes in Left and Right Ventricle Dimension
- Trial name
- NCT02595788
- Testing
- Change from supine to prone position
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Odense University Hospital
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
Aortic Valve Disease, Heart Valve Prosthesis Implantation
Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.
Objectives Primary objective: To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major complications in patients undergoing a mechanical aortic heart valve replace-ment.
- Conditions
- Aortic Valve Disease, Heart Valve Prosthesis Implantation, Anticoagulants
- Trial name
- CATHAR (NCT02128841)
- Testing
- Rivaroxaban
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Tricuspid Regurgitation
Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
This study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. The primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events.
- Trial name
- NCT06926959
- Where
- 7 sites in China
- Volunteers
- 3,000 people
- Sponsor
- Sun Yat-sen University
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
Tricuspid Valve Regurgitation
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and…
- Trial name
- NCT05194423
- Testing
- Tricuspid Valve Replacement System via jugular vein
- Where
- 9 sites in China
- Volunteers
- 150 people
- Sponsor
- Changhai Hospital
Mitral Regurgitation
Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary…
- Trial name
- MITRA-HR (NCT03271762)
- Testing
- percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW, cardiac surgery
- Where
- 31 sites in France
- Volunteers
- 330 people
- Sponsor
- Nantes University Hospital
Aortic Valve Disease
Trifecta™ Durability Study
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve.
- Trial name
- NCT01256710
- Testing
- Trifecta™ aortic bioprosthesis
- Where
- Germany
- Volunteers
- 1,151 people
- Sponsor
- Abbott Medical Devices
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
- Conditions
- Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- NCT04149600
- Testing
- Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
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 Disease
Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures.
- Trial name
- SOLO-TAVR (NCT07090811)
- Testing
- Aortic valve repair/replacement
- Volunteers
- 20 people
- Sponsor
- Solo Pace, Inc.
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
Tricuspid Regurgitation, Pulmonary Regurgitation
Berlin Registry of Right Heart Interventions
The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo.
- Trial name
- NCT04570163
- Testing
- Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Eligibility for Both Anaesthetic Methods
- Trial name
- INSERT (NCT01251328)
- Testing
- General anaesthesia, Sedation
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician…
- Trial name
- SPARC-HCM (NCT07557498)
- Testing
- Mavacamten
- Where
- United Kingdom
- Volunteers
- 362 people
- Sponsor
- Bristol-Myers Squibb
Acute Heart Failure, Mitral Regurgitation
Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients
The purpose of this study is to determine the prevalence of moderate-to-severe Mitral Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.
- Trial name
- MRAHF (NCT02728739)
- Testing
- Transthoracic Echocardiogram (TTE) Assesment
- Where
- United Kingdom
- Volunteers
- 500 people
- Sponsor
- Metanoic Health Ltd.
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