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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.

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What is this?

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 1-9 of 9 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, Minn.

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

    • Study type:

      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

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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 17-004751

    • NCT ID:

      NCT02661451

    • Sponsor Protocol Number:

      17-004751

  2. Behavior of Valve Leaflets

    Rochester, Minn.

    Behavior of Valve Leaflets

    • Study type:

      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

    This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 17-004348

    • NCT ID:

      NCT03200574

    • Sponsor Protocol Number:

      APR002

  3. Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis

    Rochester, Minn.

    Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis

    • Study type:

      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

    This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 17-003331

    • NCT ID:

      NCT03042104

    • Sponsor Protocol Number:

      2016-07

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

    Rochester, Minn.

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

    • Study type:

      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
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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 16-006932

    • Sponsor Protocol Number:

      16-006932

  5. International Bicuspid Aortic Valve Consortium (BAVCon)

    Rochester, Minn.

    International Bicuspid Aortic Valve Consortium (BAVCon)

    • Study type:

      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
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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 14-005324

    • NCT ID:

      NCT01980797

    • Sponsor Protocol Number:

      2013P000260

  6. The PARTNER 3 - AVIV Trial

    Rochester, Minn.

    The PARTNER 3 - AVIV Trial

    • Study type:

      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.

    • Study phase:

      III What is this?

      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.

    About this study

    To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

    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: 17-001387

    • NCT ID:

      NCT03003299

    • Sponsor Protocol Number:

      2015-08 AVIV

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

    Rochester, Minn.

    Comparison of Echocardiographic Parameters Between Acute and Chronic Severe Aortic Regurgitation

    • Study type:

      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

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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 16-009805

    • Sponsor Protocol Number:

      16-009805

  8. Aortic Complications in Pregnant Women with Known Bicuspid Aortic Valve

    Rochester, Minn.

    Aortic Complications in Pregnant Women with Known Bicuspid Aortic Valve

    • Study type:

      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 study aims to analyze echocardiogram data of women of reproductive age (18-45) with known bicuspid aortic valve disease and determine if pregnancy leads to increased rates of aortic dilation, surgical repair and/or dissection.

    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: 16-001376

    • Sponsor Protocol Number:

      16-001376

  9. A Study to Collect Serum Samples from Patients Presenting for Aortic Valve Replacement

    Rochester, Minn.

    A Study to Collect Serum Samples from Patients Presenting for Aortic Valve Replacement

    • Study type:

      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 identify non-HLA and non-gal protein antigens in transplanted xenogenic tissues (ie bovine pericardial heart valves) that can then be used to preemptively identify and overcome graft-specific immune responses.

    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: 17-007803

    • Sponsor Protocol Number:

      17-007803
.

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