Left Ventricular Remodeling Post-TAVR
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: 15-005570
Sponsor Protocol Number: 15-005570
About this study
There has been a paradoxical finding in clinical trials with severe AS patients that LV mass regression is greater and faster after surgical AVR compared to transcatheter AVR while hemodynamic profile is better after TAVR compared to SAVR. We do have a preliminary finding to explain this paradox and want to validate it.
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:
- 74 patients (37 TAVR and 37 SAVR) with symptomatic (NYHA Class II or greater) severe calcific aortic valve stenosis,
- age ≥50
- Valve area ≤1 cm2 OR valve area index <0.6 cm2/m2 AND mean systolic gradient >40 mmHg OR peak velocity >4 m/s OR dimensionless index <0.25
- Referred for aortic valve replacement through the Valve Clinic—37 consecutive patients undergoing TAVR and 37 consecutive patients undergoing SAVR at Mayo Clinic starting Nov 1, 2015.
Exclusion Criteria:
- Irregular rhythm (e.g. atrial fibrillation or frequent ectopy)
- Low EF aortic stenosis (EF<50%)
- Multivalvular heart disease (>moderate or previous prosthetic valve)
- Active ischemia (unstable angina, myocardial infarction, or stent placement in last 30 days prior to consent for enrollment)
- Creatinine clearance <30 cc/min
- Other cardiomyopathies—Ischemic, dilated, hypertrophic, amyloid, eosinophilic, hemochromatosis, sarcoid
- Poor echo windows/images
- Pregnancy will be effectively ruled out given the elderly population we will be studying (no patient will be less than age 50).
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 Jae Oh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available