Clinical trials: Heart Valvular Disease
Tricuspid Regurgitation, Tricuspid Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
- Trial name
- TriBAND (NCT03779490)
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
Aortic Valve Disease, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis
Surgical valve replacement is commonly performed in patients with severe aortic valve disease. In small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity.
- Trial name
- SA-AVR (NCT03976817)
- Testing
- aortic valve replacement
- Where
- France
- Volunteers
- 117 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Fontan Procedure, Hypoplastic Left Heart Syndrome
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- Trial name
- NCT00974025
- Testing
- Vitamin C
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Cardio-pulmonary Bypass, AORTIC VALVE DISEASES
Clinical Validation of a Novel Handsfree Doppler Ultrasound Device, RescueDoppler, in Adult Cardiac Surgery Patients
The goal of this study is to evaluate a new device called RescueDoppler (RD), which measures continuous blood flow in the common carotid artery. The device is handsfree and operator- independent.
- Conditions
- Cardio-pulmonary Bypass, AORTIC VALVE DISEASES, Coronary Arterial Disease (CAD), Aortic Aneurysm of the Proximal Arch
- Trial name
- RD_CPB (NCT06637540)
- Testing
- RescueDoppler
- Where
- 3 sites in Norway
- Volunteers
- 42 people
- Sponsor
- St. Olavs Hospital
Aortic Stenosis, Coronary Artery Disease
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis.
- Conditions
- Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis
- Trial name
- COMPLETE TAVR (NCT04634240)
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- 72 sites in United States, Canada
- Volunteers
- 4,000 people
- Sponsor
- University of British Columbia
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Cardiac Surgery, CAD
Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass.
Protamine is routinely used as a heparin reversal agent in cardiac surgery. However, its use may be associated with adverse events, while protamine excess may have additional anti-coagulant affect.
- Conditions
- Cardiac Surgery, CAD, Valve Heart Disease, Coagulation Disorder
- Trial name
- NCT06154018
- Testing
- Protamin
- Where
- Greece
- Volunteers
- 98 people
- Sponsor
- University of Ioannina
Arthritis of Knee, Arthritis of Hip
Comparison of the Diagnosis Time of VET and SCL in Patients With Intraoperative Coagulopathy
The present study is a prospective, multi-center observational trial comparing the times taken to diagnose coagulopathies using point-of-care (POC) viscoelastic tests or standard central laboratory tests (SCL tests) in patients…
- Conditions
- Arthritis of Knee, Arthritis of Hip, Spine, Prostate Cancer
- Trial name
- NCT06637943
- Testing
- SCL tests, POC viscoelastic tests
- Where
- 4 sites in South Korea
- Volunteers
- 210 people
- Sponsor
- Konkuk University Medical Center
Cardiac Surgery With Cardiopulmonary Bypass, Valve Heart Disease
Transfusion in Cardiac Valve Surgery
This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB).
- Trial name
- TICVS (NCT06332547)
- Testing
- Restrictive Transfusion Strategy, Liberal Transfusion Strategy
- Where
- China
- Volunteers
- 1,600 people
- Sponsor
- Guangdong Provincial People's Hospital
Rheumatic Heart Disease With Valvulitis
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according…
- Trial name
- NCT06696560
- Testing
- Minimal Invasive Approaches in Aortic surgeries.
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Yahia Abd almonem Sayed
Aortic Valve Stenosis
Sentinel Low Risk Registry
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
- Trial name
- NCT04131127
- Testing
- Sentinel Device
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- CVPath Institute Inc.
Aortic Valve Regurgitation, Mitral Valve Regurgitation
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse…
- Conditions
- Aortic Valve Regurgitation, Mitral Valve Regurgitation, Left Ventricle Dilated, Left Atrium Dilated
- Trial name
- ORMIX (NCT06805253)
- Testing
- Not applicable - observational study
- Where
- 2 sites in Russia
- Volunteers
- 120 people
- Sponsor
- Petrovsky National Research Centre of Surgery
Male Infertility, Heart Valve Disease
Warfarin Effects on Male Fertility After Cardiac Surgery
Young male patients undergoing cardiac surgery may require oral anticoagulation with warfarin either lifelong, such as after mechanical valve replacement, or for a limited postoperative period, for example following valve repair…
- Trial name
- NCT07330869
- Testing
- Semen analysis, sperm DNA fragmentation and hormonal evaluation
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Città di Lecce Hospital, GVM Care & Research
Aortic Insufficiency, Aortic Stenosis
Automated Phonocardiography Analysis in Adults
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers…
- Conditions
- Aortic Insufficiency, Aortic Stenosis, Mitral Insufficiency, Mitral Insufficiency and Aortic Stenosis
- Trial name
- NCT03600051
- Testing
- Automated Heart Murmur Detection AI
- Where
- Austria
- Volunteers
- 90 people
- Sponsor
- CSD Labs GmbH
Aortic Valve Stenosis, Valve Heart Stenosis
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy.
- Trial name
- E-AVR (NCT03143361)
- Testing
- Aortic valve replacement
- Where
- Italy
- Volunteers
- 8,000 people
- Sponsor
- University of Parma
Mitral Valve Insufficiency, Left Ventricular Systolic Dysfunction
Ertugliflozin for Functional Mitral Regurgitation
In patients with heart failure (HF) and left ventricular (LV) dilation, adverse LV remodeling causes tethering of mitral valve (MV) preventing sufficient coaptation of normal leaflets and resulting in functional MR.
- Trial name
- EFFORT (NCT04231331)
- Testing
- Ertugliflozin
- Where
- 3 sites in South Korea
- Volunteers
- 128 people
- Sponsor
- Asan Medical Center
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
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