Clinical trials: Surgical Treatment for Heart Valve Diseases
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Infective Endocarditis (IE), Heart Valve Disease
The Study Tests if Preoperative Dental Screening is Superior to no Preoperative Dental Screening in Improving the Outcome of Patients Undergoing Surgical Cardiac Valve Replacement or Transcatheter Cardiac Valve Implantation.
This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention.
- Trial name
- SMILE (NCT07511673)
- Testing
- Preoperative dental screening, No preoperative dental screening
- Where
- 5 sites in Sweden
- Volunteers
- 1,300 people
- Sponsor
- Region Skane
Mitral Regurgitation (MR)
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
- Trial name
- NCT07655505
- Testing
- Mitral Valve Repair including the use of Force Feedback instruments
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
Severe Mitral Valve Regurgitation (Disorder)
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER).
- Trial name
- TEERMISO (NCT05090540)
- Testing
- Trancatheter Edge to Edge Repair, Mitral Valve Replacement, Restrictive Mitral Annuloplastie
- Where
- 2 sites in France
- Volunteers
- 600 people
- Sponsor
- Centre Cardiologique du Nord
Anti-coagulation Therapy, DVT
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to…
- Conditions
- Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple
- Trial name
- WARFARIN (NCT01305148)
- Testing
- Warfarin GenoSTAT Test
- Where
- 56 sites in United States
- Volunteers
- 3,800 people
- Sponsor
- Iverson Genetic Diagnostics, Inc.
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
Cardiac Valve Disease, Coronary Artery Disease
Telehealth Interventions for Cardiac Surgery
The goal of this clinical trial is to compare telehealth monitoring at home against usual care in patients undergoing planned heart surgery. The main questions it aims to answer are: 1.
- Conditions
- Cardiac Valve Disease, Coronary Artery Disease, Surgical Complication
- Trial name
- TICS (NCT05621954)
- Testing
- Telehealth Monitoring
- Where
- United Kingdom
- Volunteers
- 318 people
- Sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
Mitral Valve Regurgitation
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation
KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques.
- Trial name
- NCT03908983
- Testing
- Kalios Implant
- Where
- 9 sites in Austria, Germany and 2 more
- Volunteers
- 100 people
- Sponsor
- Kephalios
Ascending Aorta Aneurism, Aortic Insufficiency
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
- Trial name
- EPSTAAA (NCT01456975)
- Testing
- Aortic valve reimplantation using Valsalva prosthesis
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Mitral Insufficiency, Pulmonary Arterial Hypertension
Surgical Valvuloplasty for Congenital Mitral Insufficiency
Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly.
- Trial name
- NCT03567668
- Testing
- mitral valvuloplasty
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hong Liu
Coronary Artery Bypass Grafting, Surgical Treatment for Heart Valve Diseases
China Cardiovascular Surgery Registry
China Cardiovascular Surgery Registry (CCSR) Study is a national database for coronary artery bypass grafting (CABG) and valve surgery performed in 87 hospitals with cardiovascular surgery volume > 100 per year.
- Trial name
- CCSR (NCT02400125)
- Where
- China
- Volunteers
- 90,000 people
- Sponsor
- China National Center for Cardiovascular Diseases
Systemic Right Ventricle, Tricuspid Regurgitation
Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort (PETER-TRESRIV)
Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve…
- Conditions
- Systemic Right Ventricle, Tricuspid Regurgitation, Congenital Heart Disease
- Trial name
- PETER-TRESRIV (NCT05052177)
- Testing
- Edge to edge repair in systemic tricuspid valve regurgitation
- Where
- France
- Volunteers
- 10 people
- Sponsor
- University of Bordeaux
Barlow's Disease, Prolapse; Mitral
Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.
- Trial name
- NCT04002648
- Testing
- Right minithoracotomy, Sternotomy
- Volunteers
- 208 people
- Sponsor
- Ospedale San Raffaele
Aortic Diseases, Aortic Dissection
Proximal Aortopathy in Scotland - Epidemiology and Surgical Outcomes
The aorta is the principal arterial vessel arising from the left heart that transfers blood to the body. Certain genetic and familial disease processes are known to weaken the aortic wall resulting in dilation and potential…
- Conditions
- Aortic Diseases, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Ectasia
- Trial name
- NCT05389865
- Testing
- Surgery on the proximal aorta (aortic root +/- ascending aorta), Patients diagnosed with thoracic aortopathy but not operated upon
- Where
- United Kingdom
- Volunteers
- 1,662 people
- Sponsor
- Golden Jubilee National Hospital
Hypertrophic Obstructive Cardiomyopathy
Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
- Trial name
- PRIZMA-pilot (NCT04470102)
- Testing
- mitral valve repair by edge-to-edge technique, Septal myectomy
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Congenital Heart Disease
Autus Valve Pivotal Study
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT05006404
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- 12 sites in United States
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Alternative Surgical Treatment for Aortic Valve Disease
TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St.
- Trial name
- TriRec (NCT03600662)
- Testing
- TriRec, Aortic valve replacement
- Where
- Germany
- Volunteers
- 128 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Stenosis, Multi Vessel Coronary Artery Disease
The TransCatheter Valve and Vessels Trial
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and…
- Conditions
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG
- Trial name
- TCW (NCT03424941)
- Testing
- FFR-guided PCI and TAVI, CABG and SAVR
- Where
- 20 sites in Austria, Denmark and 8 more
- Volunteers
- 172 people
- Sponsor
- Maatschap Cardiologie Zwolle
Type A Aortic Dissection, Ascending Aortic Dissection
Outcomes of Aortic Dissection Repair
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity.
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch
- Trial name
- STAAD (NCT05927090)
- Testing
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR), Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Centre Cardiologique du Nord