Shockless IMPLant Evaluation in Replacements

Overview

About this study

The purpose of this study is to demonstrate the event rate of the primary outcome, defined as failure of DFT at a single shock at 10 Joules below maximal capacity of the device.

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:

Patients with an ICD or Cardiac Resynchronization Therapy Device (CRT-D) undergoing pocket generator replacement.
Age ≥ 18 years

Exclusion Criteria:

If there is an absolute contraindication to DFT testing
1. NYHA class IV
2. Atrial fibrillation (AF) > 24 hours unless on oral anticoagulation or negative TEE
3. Recent anoxic brain injury
Obvious lead malfunction (i.e. short V-V intervals, inappropriate shock for noise, clear fracture on Chest X-ray, etc.)
Unwilling to provide written informed consent
Unavailable for Follow-up
Pregnancy (or women of child-bearing potential not taking or willing to take an effective method of contraception).

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 Yong-Mei Cha, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Yong-Mei Cha, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials