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What is this?
A volunteer subject with no known significant health problems who participates in research to test a new drug, device or intervention. These volunteers are recruited to serve as controls for patient groups. Healthy volunteers receive the same test, procedure, or drug the patient group receives.

Study phase

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During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Search Results 1-10 of 28 for Aortic valve repair and aortic valve replacement

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  1. Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

    Rochester, MN

    Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

    • Location:

      Interventional What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 17-004751

    • NCT ID:

      NCT02661451

    • Sponsor Protocol Number:

      17-004751

  2. International Bicuspid Aortic Valve Consortium (BAVCon)

    Rochester, MN

    International Bicuspid Aortic Valve Consortium (BAVCon)

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability.

    The Specific Aims of this study are:

    1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.

    2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease.

    To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 14-005324

    • NCT ID:

      NCT01980797

    • Sponsor Protocol Number:

      2013P000260

  3. A Study of Information Provided by Cardiopulmonary Exercise Testing When Evaluating Patients with Aortic Stenosis

    Rochester, MN

    A Study of Information Provided by Cardiopulmonary Exercise Testing When Evaluating Patients with Aortic Stenosis

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to find if cardiopulmonary exercise testing data will provide any predictive information in evaluating patients with aortic stenosis for severity, symptoms and surgical risk.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 15-007706

    • Sponsor Protocol Number:

      15-007706

  4. Comparison of Echocardiographic Parameters Between Acute and Chronic Severe Aortic Regurgitation

    Rochester, MN

    Comparison of Echocardiographic Parameters Between Acute and Chronic Severe Aortic Regurgitation

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to compare echocardiographic between acute and chronic severe AR patients at baseline and after surgical aortic valve replacement.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 16-009805

    • Sponsor Protocol Number:

      16-009805

  5. New-onset Atrial Fibrillation and Flutter Following Cardiac Surgery

    Rochester, MN

    New-onset Atrial Fibrillation and Flutter Following Cardiac Surgery

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The aims of this investigation are:

    To assess the predictive value (and accuracy) of clinical and physiologic preoperative variables in identifying patients at risk for the development of new-onset atrial arrhythmia after cardiac surgery.

    To assess the feasibility of a physiological risk model based on clinical and echocardiographic indexes to predict post-operative AF.

    To assess the role of prophylactic agents in the prevention of new-onset postoperative POAF

    To assess the economic impact of new-onset postoperative AF:

    • Length of hospital stay (will be measured as fractions of days)

    • Hospital cost (will be measured in standardized dollars)

    • Resource utilization (will be measured by resource-based relative-value units)

    To assess the outcome of patients who develop early atrial fibrillation following cardiac surgery:

    • To assess whether first time new-onset POAF predicts long-term AF.

    • Examine the predictive value of potential preoperative variables in identifying patients at risk of developing

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 08-005799

    • Sponsor Protocol Number:

      08-005799

  6. Transapical and Transfemoral TAVR, Two Different Patient Populations with Possible Similar Clinical and Cardiac Mechanics Outcomes

    Rochester, MN

    Transapical and Transfemoral TAVR, Two Different Patient Populations with Possible Similar Clinical and Cardiac Mechanics Outcomes

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    Compare transapical and transfemoral TAVR as regards clinical outcomes (both beneficial including improvement in heart failure class (NYHA) and reduced number of hospitalizations; and adverse including mortality and MACE.) Also, to compare cardiac mechanics’ outcomes in the short and intermediate follow up and correlate the baseline, percent change and final cardiac mechanics values with the clinical outcomes. So that this all comes down to being able to provide these information to the patients if there appeared to be a correlation between cardiac mechanics and clinical outcomes:

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Contact us for the latest status

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 16-006932

    • Sponsor Protocol Number:

      16-006932

  7. A Study to Assess the Effect of Lower Hemoglobin Levels on Cardiac Functions in Patients with Cardiac Diseases

    Rochester, MN

    A Study to Assess the Effect of Lower Hemoglobin Levels on Cardiac Functions in Patients with Cardiac Diseases

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to test if a reduction of hemoglobin leads to subclinical cardiac dysfunction in patients with known cardiovascular disease.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed-enrolling by invitation

    What is this? (?)

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 17-010787

    • Sponsor Protocol Number:

      17-010787

  8. The Effects of Aortic Valve Replacement on Sleep Disordered Breathing, Heart Rate Variability and Ventricular Ectopy Burden in Patients with Severe Aortic Stenosis

    Rochester, MN

    The Effects of Aortic Valve Replacement on Sleep Disordered Breathing, Heart Rate Variability and Ventricular Ectopy Burden in Patients with Severe Aortic Stenosis

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    Our overall goal is to determine whether the AVR improves SDB where present and sleep profiles (including sleepiness symptoms, quality of life and hypoxia).

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 17-001309

    • Sponsor Protocol Number:

      17-001309

  9. A Study of Strain Echocardiography in Assessment of Valvular Heart Disease

    Rochester, MN

    A Study of Strain Echocardiography in Assessment of Valvular Heart Disease

    • Location:

      Observational What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    Classical echocardiographic assessment of heart valves is critical in determination of disease severity. However, echocardiography has only limited ability to predict how well an individual patient will do at time of surgery. New echocardiographic technology allows us to measure new, more refined parameters of your heart’s performance. This study is investigating whether these new parameters are better in predicting outcomes.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed-enrolling by invitation

    What is this? (?)

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 13-000009

    • Sponsor Protocol Number:

      13-000009

  10. Left Ventricular Ejection Hemodynamics in Patients with Hypertrophic Cardiomyopathy and Valvular Aortic Stenosis

    Rochester, MN

    Left Ventricular Ejection Hemodynamics in Patients with Hypertrophic Cardiomyopathy and Valvular Aortic Stenosis

    • Location:

      Interventional What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to compare ejection hemodynamics in patients with obstructive hypertrophic cardiomyopathy (HCM) before and after septal myectomy.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 15-004606

    • Sponsor Protocol Number:

      15-004606
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