Clinical trials: Surgical Valve Replacement
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability
Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction, Electro-acupuncture
- Trial name
- FRESH-T (NCT07365345)
- Testing
- electrical acupoint stimulation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Air Force Military Medical University, China
High-surgical Risk Patients with Severe Tricuspid Regurgitation
Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement
The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers.
- Trial name
- The TRI-RECRUI (NCT06862765)
- Testing
- transcatheter tricuspid valve replacement
- Where
- 8 sites in China
- Volunteers
- 340 people
- Sponsor
- Xijing Hospital
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Rheumatic Valve Disease
Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery
The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.
- Trial name
- NCT00732459
- Testing
- Electro-acupuncture preconditioning
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Xijing Hospital
Aortic Valve Disease
Ross for Valve Replacement in AduLts Trial
This study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure versus conventional aortic valve replacement using a biologic or mechanical heart valve.
- Trial name
- REVIVAL (NCT03798782)
- Testing
- Ross procedure, Conventional aortic valve replacement
- Where
- Canada
- Volunteers
- 43 people
- Sponsor
- Population Health Research Institute
Allografts, Tricuspid Valve Insufficiency
Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.
- Trial name
- ESEMATS (NCT06196684)
- Testing
- Mitral allograft implantation
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- Chelyabinsk Regional Clinical Hospital
Aortic Valve Disease, Mitral Valve Disease
VIenna Pilot Study for Automated Annular Suturing Technology
The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology.
- Trial name
- VIP-RAM (NCT04659655)
- Testing
- automated annular suturing
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Medical University of Vienna
Aortic Valve Stenosis, Bicuspid Aortic Valve
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVE-IT (NCT06817148)
- Testing
- transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Stenosis
PERIGON Pivotal Trial
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
- Trial name
- PERIGON (NCT02088554)
- Testing
- Model 400 aortic valve bioprosthesis
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 1,312 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Valve Stenosis
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
- Trial name
- NCT07205341
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HemoCept Inc.
Transcatheter Aortic Valve Replacement, Cardiac Valve Annuloplasty
Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery
The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery.
- Trial name
- ACTPOC (NCT04785885)
- Testing
- iStat Handheld Blood Analyzer, Hemochron
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rhode Island Hospital
Right Ventricular Dysfunction
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction.
- Trial name
- TOF-Cond (NCT00557934)
- Testing
- dobutamine
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital Tuebingen
Aortic Valve Replacement
Homoeopathic Association in Aortic Valve Surgery
Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation…
- Trial name
- OMEO (NCT00774293)
- Testing
- Arnica and Bryonia
- Where
- France
- Volunteers
- 92 people
- Sponsor
- BOIRON
Surgery, Survival, Prosthesis
15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).
- Conditions
- Surgery, Survival, Prosthesis, Valve Heart Disease
- Trial name
- ANDALVALVE (NCT03239509)
- Testing
- bioprosthesis implantation between 2000-2015, mechanical prosthesis implantation between 2000-2015
- Where
- 7 sites in Spain
- Volunteers
- 1,200 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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
Cardiac Valve Disease
Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries
Comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.
- Trial name
- NCT06076759
- Testing
- Intrathecal morphine or dexmedetomidine
- Volunteers
- 40 people
- Sponsor
- Assiut University
Surgery--Complications, Cardiac Valve Disease
Prevention of Acute Kidney Injury by N-Acetylcystein in Patients Undergone Cardiac Valve Replacement
This is a randomized clinical trial, double-blind, placebo-controlled study with the goal to assess the influence of using N-AcetylCysteyn (NAC) for prevention of AKI (Acute Kidney Injury) in post operatory of valve replacement…
- Conditions
- Surgery--Complications, Cardiac Valve Disease, Acute Kidney Injury, Oxygen Radical Damage
- Trial name
- NCT03440268
- Testing
- N Acetyl Cysteine
- Where
- Brazil
- Volunteers
- 154 people
- Sponsor
- University of Sao Paulo General Hospital
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Degenerative Aortic Valve Disease
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke…
- Trial name
- REPEAT (NCT07462624)
- Testing
- Transfemoral transcatheter valve-in-valve implantation, Surgical redo aortic valve replacement
- Where
- Germany
- Volunteers
- 890 people
- Sponsor
- Heart Center Leipzig - University Hospital