Comparison of Short and Long-Term Outcomes between Surgical Septal Myectomy and Alcohol Septal Ablation
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: 16-006116
Sponsor Protocol Number: 16-006116
About this study
The standard of care for obstructive hypertrophic cardiomyopathy (HCM) refractory to medical therapy is surgical septal myectomy. Percutaneous transluminal septal myocardial ablation, otherwise known today as alcohol septal ablation (ASA) has been growing as a favorable alternative to myectomy. There have been no randomized controlled trials conducted to evaluate ASA versus surgical myectomy. The purpose of this study is to compare overall survival between surgical septal myectomy and alcohol septal ablation. The study will also compare periprocedural and long-term complication rates for both myectomy and alcohol septal ablation. Furthermore, the study willl determine the rates of re-intervention for both myectomy and alcohol septal ablation and identify predictors of the need for re-intervention.
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 diagnosed with hypertrophic cardiomyopathy, who subsequently underwent isolated septal myectomy or alcohol septal ablation.
Exclusion Criteria:
- age < 18
- Concomitant cardiac surgery in addition to myectomy
- Nnonobstructive physiology (normal LVOT gradient at rest or provoked)
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