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

Overview

  • Study type

    Observational
  • Study IDs

  • 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.
  • Site IRB
    • Rochester, Minnesota: 16-006932
    Sponsor Protocol Number: 16-006932

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:

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Consecutive patients who have had either Transapical or transfemoral TAVR

Exclusion Criteria: 

  • Unsucessful procedures e.g. Procedures complicated with more than moderate aortic incompetence.
  • Arrhythmias e.g. conduction delays and atrial fibrillation
  • Patient denied Mayo Clinic authorization to participate in research

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sorin Pislaru, M.D., Ph.D.

Contact us for the latest status

Contact information:

Sorin Pislaru M.D., Ph.D.

(507)284-8612