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. 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:

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Siva Mulpuru, M.D., M.P.H.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Siva Mulpuru, M.D., M.P.H.

Closed for enrollment

More information

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