Heart Valve Disorders

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Heart Valve Disorders

General Purpose:

There are four valves in your heart that are constantly working to keep blood flowing in the right direction. They include the aortic valve, mitral valve, pulmonary valve, and tricuspid valve. Each time your heart beats, these four valves simultaneously open and close.

Occasionally, something can go wrong and one of the valves may not open or close as it should. As a result, the flow of blood through the heart is disrupted, which creates a chain reaction of disrupted blood flow through the body.

Stenosis occurs when a particular valve fails to open like it should. Regurgitation occurs when a valve doesn’t close properly and therefore has the potential to leak.

Stenosis and regurgitation can affect any of the four valves of the heart, and treatment is dictated by the particular valve that is affected and how severe the stenosis or regurgitation is. Some heart valve disorders are the result of underlying heart disease or result from a heart attack, while others occur when an infection attacks the valve itself.

Many heart valve disorders arise when the heart does not develop properly during fetal development, and are therefore considered congenital, or birth defects. In total, approximately five million individuals in the United States are diagnosed with some form of heart valve disease each year. 

Receiving a diagnosis of heart valve disease can be a frightening experience, but it doesn’t have to be. Many heart valve diseases can be successfully treated and managed with medication and surgery, and even repaired with transplanted valves or tissues from humans and even animals. 

Fortunately, research related to heart valve disease is abundant and thriving, with great strides being made every day with regard to improved methods of detection, diagnosis, treatment, and even prevention.

What Will Heart Valve Disorders Clinical Trials Be Like?

The types of tests and assessments used in heart valve disorder clinical trials will ultimately depend on the specific nature of the study and more importantly, which particular heart valve disease (or diseases) is/are being studied. Provided below is a list ofHeart Valve Disorders frequent procedures and tests used to evaluate the heart, heart functioning, and its impact on the body in general, many of which may be incorporated for use in clinical trials: 

  • Physical exam
  • Detailed family history of heart diseases.
  • Genetic testing
  • Cardiac catheterization: a procedure during which a long, thin, and flexible tube (i.e., catheter) is inserted into a blood vessel in the arm, upper thigh, or neck and threaded through until it reaches your heart. This allows doctors to perform diagnostic tests and treatments, as well as to evaluate blockages in the blood vessels.
  • Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans: these are non-invasive imaging procedures, similar to an x-ray, that allow doctors to take detailed pictures of your heart.
  • Coronary angiography: a procedure during which a dye is injected into a vein in your arm and then viewed using a special x-ray machine, CT scanner, or MRI machine. This allows doctors to view the insides of the arteries that provide blood to your heart. Angiography may also be used to evaluate other blood vessels throughout the body.
  • Echocardiography (“echo”): a painless procedure that uses ultrasound to create moving pictures of your heart, which allow doctors to see its size, shape, and how well it is working. During a procedure known as transesophageal echocardiography, a long, thin ultrasound probe is guided down the throat into the esophagus, which is directly behind the heart, in order to obtain more detailed pictures.
  • Electrocardiogram (EKG, or ECG): a straightforward and painless procedure that records the electrical activity of the heart. This test tells doctors how fast your heart is beating, the regularity (or irregularity) of your heart rhythm, and strength and timing of the electrical signals that constantly pass through the heart.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Blood tests to look for chemical markers that are associated with particular heart valve diseases and other heart diseases in general.
  • Nuclear heart scan: a test that uses a small but safe amount of a radioactive compound, injected into your body through a vein in the arm. This compound then travels to the heart and allows special cameras to take detailed pictures of the heart to evaluate 1) blood flow; 2) damaged heart muscle; and 3) pumping ability and efficiency.
  • Stress test: a test performed while you exercise (usually by walking or running on a treadmill, or pedaling a stationary bicycle), which allows doctors to evaluate how your heart works during episodes of physical stress.
  • Pain and quality of life assessments, as well as exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Heart Valve Disease Clinical Trial Protocol:

Specific examples of clinical trials for heart valve disease might include the following:

  • A randomized clinical trial in which a specific beta-blocker (a drug used to regulate heart rhythm) is given to patients with mitral regurgitation who are scheduled to receive surgery to treat their disease. In this study, those patients would be compared with two other groups: patients with mitral regurgitation who receive surgery but who are not treated with the beta-blocker, and healthy volunteers (i.e., control subjects) who have no significant medical history and are not currently taking any medications. The purpose of this study would be to determine if receiving the beta-blocker provides any added benefit to those patients who receive surgery to treat their mitral regurgitation.
  • A long-term study in which patients with aortic stenosis are treated with a cholesterol-lowering drug to determine if the drug is able to slow (or altogether stop) the narrowing of the aortic valve.
  • A long-term study in which individuals who receive surgery to repair tricuspid valve regurgitation are followed over a 10  year period to assess their mortality, need for additional surgery, incidence of atrial fibrillation, and number of hospitalizations.
  • A study in which patients with pulmonary stenosis, who receive valve replacement with a particular type of synthetic pulmonary valve, are followed for a six month period so that data can be collected by researchers to help establish the safety and efficacy of the synthetic valve.

A brief word about randomized trials and placebos: 

Heart Valve DisordersMany clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your specific heart valve disease, any other history of heart disease, your treatment history, and a variety of clinical findings. Therefore, it is important to know many details Heart Valve Disorderspertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your specific diagnosis of heart valve disease (e.g., pulmonary valve stenosis, aortic regurgitation)
  • Your prior history of heart disease
  • Your family history of heart disease
  • Your prior history of treatment for heart disease (including any surgeries, procedures, and medications)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels

Suggested Search Terms:

Once you are ready to begin your search for heart valve disease clinical trials, it is advisable for you to search using your specific diagnosis (e.g., mitral regurgitation, tricuspid regurgitation, aortic stenosis, etc.) combined with any of the following terms: “management,” “treatment,” “prevention,” “genetics,” “family history,” “birth defects,” “congenital,” “children,” “pediatric,” “infection,” “rehabilitation,” “transplant,” “pregnancy,” “replacement,” and “surgery.”

Current Search Term:

“Heart Valve Disorders”

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Medtronic HAMMOCK Post Approval Study

Condition:   Heart Valve Diseases
Intervention:   Device: Mosiac model 305, model 310, and ultra model 305
Sponsor:   Medtronic Cardiovascular
Not yet recruiting - verified May 2017

Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University

Condition:   Valvular Heart Disease
Sponsor:   Second Affiliated Hospital, School of Medicine, Zhejiang University
Not yet recruiting - verified December 2016

Effects of Hyperoxia on Open Heart Surgery

Conditions:   Heart Valve Disease;   Coronary (Artery) Disease
Interventions:   Other: Fraction of inspired oxygen 40%;   Other: Fraction of inspired oxygen 100%
Sponsors:   Istanbul University;   Koşuyolu Kartal Heart Training and Research Hospital
Recruiting - verified January 2017

Saint Luc Valve Registry

Condition:   Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
Sponsor:   Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Recruiting - verified November 2016

China Senile Valvular Heart Disease Cohort Study

Condition:   Heart Valve Diseases
Sponsors:   China National Center for Cardiovascular Diseases;   Ministry of Science and Technology of the People´s Republic of China
Not yet recruiting - verified August 2016

Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography

Conditions:   Heart Valve Disease;   Heart Septal Defects, Atrial
Interventions:   Drug: Dexmedetomidine;   Drug: Ketofol(ketamine+propofol)
Sponsor:   Postgraduate Institute of Medical Education and Research, Chandigarh
Recruiting - verified August 2016

Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study)

Condition:   Valve Heart Diseases
Interventions:   Device: Cardiac MRI;   Biological: blood samples;   Procedure: myocardial biopsy;   Genetic: blood samples
Sponsor:   Assistance Publique Hopitaux De Marseille
Not yet recruiting - verified July 2016

Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Conditions:   Aortic Valve Stenosis;   Heart Valve Disease
Intervention:   Other: 4-dimensional volume-rendered computed tomography
Sponsors:   Karolinska University Hospital;   Karolinska Institutet
Completed - verified July 2016

Influence of a Rehabilitation in Valve Replacement on Heart Rate Variability and Oxidative Stress

Condition:   Cardiac Valve Disease
Intervention:   Other: physical therapy procedure
Sponsor:   Universidade Metodista de Piracicaba
Recruiting - verified October 2016

coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)

Conditions:   Heart Valve Diseases;   Coronary Artery Disease
Intervention:   Other: Computed tomographic angiography
Sponsors:   Chinese Academy of Medical Sciences, Fuwai Hospital;   Guangdong General Hospital;   West China Hospital;   Fourth Military Medical University;   Wuhan Union Hospital, China
Recruiting - verified September 2016

Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")

Condition:   Heart Valve Disease
Intervention:   Other: Decellularized human heart valves
Sponsors:   corlife;   Hannover Medical School;   Leiden University Medical Center;   Azienda Ospedaliera di Padova;   Hospital Clinic of Barcelona;   Royal Brompton & Harefield NHS Foundation Trust;   Universitaire Ziekenhuizen Leuven;   Heinrich-Heine University, Duesseldorf;   Vienna General Hospital
Recruiting - verified August 2016

The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass

Condition:   Valvular Heart Disease
Interventions:   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: ERAS group;   Procedure: Conventional control group;   Procedure: ERAS group;   Procedure: Conventional control group;   Procedure: Conventional control group;   Procedure: Conventional control group;   Procedure: Conventional control group;   Procedure: Conventional control group;   Procedure: Conventional control group
Sponsor:   Xiangya Hospital of Central South University
Active, not recruiting - verified February 2017

RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial

Condition:   Valvular Heart Disease
Interventions:   Drug: Rivaroxaban;   Drug: Warfarin
Sponsor:   Hospital do Coracao
Recruiting - verified December 2016

Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Conditions:   Aortic Valve Stenosis;   Heart Valve Diseases
Interventions:   Procedure: Minimally invasive aortic valve replacement;   Procedure: Full sternotomy aortic valve replacement
Sponsors:   Karolinska University Hospital;   Karolinska Institutet
Recruiting - verified November 2016

European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

Condition:   Heart Valve Disease
Intervention:   Other: Decellularized human valves
Sponsors:   corlife;   Hannover Medical School;   State University of Medicine and Pharmaceutics, Chisinau, Moldavia;   Leiden University Medical Center;   Great Ormond Street Hospital for Children NHS Foundation Trust;   University of Padova;   Hôpital Necker-Enfants Malades;   University of Zurich;   Universitaire Ziekenhuizen Leuven;   German Society for Tissue Transplantation;   European Homograft Bank;   Gottfried Wilhelm Leibniz Universität Hannover
Recruiting - verified January 2017

D-dimer and Oral Anticoagulation Therapy in Patients With Mechanical Valve Replacement

Condition:   Heart Valve Disease
Intervention:   Drug: Warfarin
Sponsor:   Wuhan Asia Heart Hospital
Completed - verified December 2015

Cardiac Function After Minimally Invasive Aortic Valve Implantation

Conditions:   Aortic Valve Stenosis;   Heart Valve Diseases
Interventions:   Procedure: Minimally invasive aortic valve replacement;   Procedure: Conventional aortic valve replacement
Sponsors:   Karolinska University Hospital;   Karolinska Institutet
Completed - verified August 2016

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Conditions:   Congenital Heart Disease;   Heart Valve Disease
Intervention:   Drug: simvastatin
Sponsor:   Sun Yat-sen University
Recruiting - verified April 2017

A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve

Conditions:   Anticoagulation Treatment Overdose;   Heart Valve Diseases
Interventions:   Other: Genotype-based Warfarin Initiation model;   Other: clinical factor-based warfarin initiation model
Sponsors:   Xi Zhang;   Sun Yat-sen University
Recruiting - verified July 2016

Magna Mitral - 23mm

Condition:   Mitral Heart Valve Disease
Intervention:   Device: Implantation of CEP Magna Mitral Model 7000TFX
Sponsor:   Edwards Lifesciences
Active, not recruiting - verified September 2016

ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

Condition:   Heart Valve Diseases
Intervention:   Device: ATS 3f Enable Aortic Bioprosthesis Model 6000
Sponsor:   Medtronic Cardiovascular
Completed - verified October 2016

ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

Condition:   Heart Valve Diseases
Intervention:   Device: ATS 3f Aortic Bioprosthesis
Sponsor:   Medtronic Cardiovascular
Terminated - verified April 2017

Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Condition:   Heart Valve Diseases
Intervention:   Device: Freedom SOLO
Sponsor:   LivaNova
Active, not recruiting - verified November 2016

ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm

Condition:   Heart Valve Diseases
Intervention:   Device: ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm
Sponsor:   Medtronic Cardiovascular
Terminated - verified June 2016

Randomized On-X Anticoagulation Trial

Condition:   Heart Valve Disease
Interventions:   Device: On-X valve using reduced anticoagulation;   Device: On-X Valve with Standard warfarin Therapy
Sponsors:   On-X Life Technologies, Inc.;   Clinipace LTD;   Alere, Inc.
Recruiting - verified April 2017

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