A Study of Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death

Overview

About this study

The purpose of this study is to evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.

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.

Inclusion Criteria: 

  • Any scar-related sustained VT or VF.
  • Class I, IIa, or IIb indication for secondary prevention ICD therapy per ESC Guidelines. 
  • Age ≥ 18 years on date of consent.
  • LVEF ≤ 40%.
  • Positive ECG screening for S-ICD.

Exclusion Criteria:

  • A requirement for antibradycardia pacing or CRTD.
  • Subjects with an existing trans-venous ICD, CRT, CRT-D, or pacemaker device. 
  • Existing S-ICD implanted for secondary prevention
  • Contraindications for S-ICD implantation.
  • Contraindications for VT ablation. 
  • Serious known concomitant disease with a life expectancy of < 1 year.
  • Elderly patients > 80 years of age.
  • NYHA class IV or need for mechanical LV support (ECMO). 
  • Pregnancy or nursing.
  • Unwilling or unable to give informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Siva Mulpuru, M.D.

Contact us for the latest status

Contact information:

Siva Mulpuru M.D.

(507)255-2504

Mulpuru.Siva@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-20467296

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