A Study to Evaluate Long-term Outcomes of Alcohol Septal Ablation for Hypertrophic Cardiomyopathy

Overview

About this study

The purpose of this study is to determine long term vital status, symptoms, and need for repeat procedure after alcohol septal ablation, to determine patient and procedural factors associated with successful alcohol septal ablation and need for repeat procedure, and to determine the impact of conduction abnormalities after alcohol septal ablation on long-term 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. 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:

  • All patients 18 years or older that were evaluated at the Mayo Cardiomyopathy Clinic and underwent septal ablation between 1998 – 02/28/2019 at Mayo Clinic.
  • Each patient met the following criteria to be considered for septal ablation:
    • severe, drug-refractory cardiovascular symptoms, which was defined New York Heart Association class III/IV dyspnea, Canadian Cardiac Society angina class III/IV, or disabling syncope; 
    • dynamic LVOT obstruction due to systolic anterior motion of the mitral valve, with an LVOT gradient ≥ 30 mm Hg at rest or ≥ 50 mm Hg with provocation (e.g., Valsalva strain, amyl nitrate inhalation, and postectopic beat analysis); 
    • ventricular septal thickness ≥ 15 mm; 
    • no significant intrinsic mitral valve disease; 
    • absence of need for concomitant cardiac surgical procedure (e.g., bypass grafting and valve replacement);
    • suitable coronary anatomy; and 
    • informed patient consent.
    • The choice of alcohol septal ablation or surgical myectomy was made through a shared decision-making process after discussion of the risks of benefits of each alternative.

Exclusion Criteria: 

  • Patients who underwent septal ablation for purposes other than relieving severe dynamic LVOT obstruction (e.g., in preparation of transcatheter mitral valve replacement).

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Contact us for the latest status

Contact information:

Mackram Eleid M.D.

(507)293-6168

Eleid.Mackram@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20471735

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