Clinical trials: Surgical Valve Replacement
Echocardiography, Aortic Valve
Short- and Medium-term Results of New Generation Aortic
Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used.
- Conditions
- Echocardiography, Aortic Valve, Cardiac Surgery, Mortality
- Trial name
- RVANG (NCT05055089)
- Where
- France
- Volunteers
- 172 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
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
Open Mitral Cardiac Surgery
Role of Left Stellate Ganglion Block in Offering Myocardial Protection in On-pump Mitral Valve Replacement? A Histopathological and Clinical Assessment
Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment.
- Trial name
- NCT06476925
- Testing
- sonar guided stellate ganglion injection, sonar guided stellate ganglion block
- Where
- Egypt
- Volunteers
- 62 people
- Sponsor
- Minia University
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
Aortic Stenosis, Amyloid
Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement
Background (Context): Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart.
- Trial name
- AORTICMARKER (NCT07105501)
- Where
- Spain
- Volunteers
- 110 people
- Sponsor
- Germans Trias i Pujol Hospital
Myocardial Infarction, Percutaneous Coronary Intervention
Text Message Intervention to Improve Cardiac Rehab Participation
Cardiac rehabilitation (CR) is strongly recommended for patients with coronary heart disease. However, patient enrollment and completion of cardiac rehabilitation is low.
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, Heart Valve Repair or Replacement
- Trial name
- NCT03346278
- Testing
- Text Messaging Intervention
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Washington
Mechanical Aortic and/or Mitral Valve Replacement Operation
Patient International Normalised Ratio (INR) Self-Testing Program
The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic…
- Trial name
- NCT00925197
- Testing
- INR self-testing program
- Volunteers
- 206 people
- Sponsor
- University Hospital, Clermont-Ferrand
Aortic Stenosis, Severe
The CardioFit Trial: Exercise Training Before Aortic Valve Surgery
The CardioFit Trial: The feasibility, safety and tolerability of an exercise training programme in patients with severe aortic stenosis prior to aortic valve replacement surgery: A feasibility trial To investigate if a Structured…
- Trial name
- CardioFit (NCT06818110)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Aortic Stenosis
The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery
This study is looking at the effects of high spinal anesthesia (also known as total spinal anesthesia) combined with general anesthesia versus general anesthesia alone on the following: Stress response: Patients undergoing aortic…
- Trial name
- NCT00348920
- Testing
- High Spinal and General Anesthesia
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- University of Manitoba
Mitral Valve or Aortic Valve Replacement
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace…
- Trial name
- NCT02381678
- Testing
- Perimount 2900/6900 Heart Valve
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Mitral Valve Insufficiency, Coronary Artery Disease
Long Term Follow Up for CTSN Mitral Valve Repair Studies
This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about…
- Trial name
- NCT03066050
- Testing
- MV Repair, MV Replacement, CABG
- Where
- 24 sites in United States, Canada
- Volunteers
- 368 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or…
- Trial name
- NCT05784337
- Testing
- Mi-thos® Transcatheter Mitral Valve Replacement System
- Where
- 2 sites in China
- Volunteers
- 11 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk.
- Trial name
- TOGETHER (NCT05711186)
- Testing
- Structured SDM, Usual Care
- Where
- 2 sites in Switzerland
- Volunteers
- 140 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Inflammation
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical…
- Trial name
- APPIRED-II (NCT01144611)
- Testing
- bIAP bolus and 8h infusion
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Alloksys Life Sciences B.V.
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Inflammasomes, Cognitive Dysfunction
Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve Replacement Surgery
The investigators decided to assess the prognostic value of NLRP3 inflammasome level in early after heart valve replacement surgery and whether it was related to postoperative cognitive dysfunction.
- Conditions
- Inflammasomes, Cognitive Dysfunction, Pyrin Domain-Containing 3 Protein, Postoperative Complications
- Trial name
- NCT04191642
- Where
- China
- Volunteers
- 75 people
- Sponsor
- General Hospital of Ningxia Medical University
Pathological Processes, Cardiomyopathies
Adenosine as an Adjunct to Blood Cardioplegia
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction.
- Trial name
- NCT02681913
- Testing
- Adenosine
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Amphia Hospital