A Study of Virtual Three Dimensional Modeling of Heart in Preoperative Planning of Myectomy in Patients with Hypertrophic Cardiomyopathy
Overview
Tab Title Description
Study type
ObservationalDescribes 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 IDs
Site IRB
- Rochester, Minnesota: 17-008904
Sponsor Protocol Number: 17-008904
About this study
The purpose of this study is to:
-
Determine the structural accuracy of virtual three dimensional models of heart in patients with hypertrophic cardiomyopathy (HCM).
- To explore the utility of virtual three dimensional modeling of heart in pre-operative planning of myectomy in patients with hypertrophic cardiomyopathy (HCM).
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults ≥ 18 years of age
- Attending HCM clinic at Mayo Clinic Rochester
- Diagnosed with HCM with LVOT obstruction
- Referred to Cardiovascular Surgery at Mayo Clinic for elective surgical septal myectomy
Exclusion Criteria:
- Concomitant procedures for Coronary Artery Disease, Atrial Fibrillation or other valvular diseases.
- Those who lack capacity who give informed consent.
- < 18 years of age
- Patients who have implanted metal devices; (pacemakers, pumps, etc.)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Hartzell Schaff, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available