This is an acute data collection study for pacing feasibility Circulatory System
Conditions
Interventions
This trial will be testing the feasibility of pacing the heart with a research system. The results of the study will provide data to support Medtronic in the research and development of a potential ex
Sponsors
Medtronic (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must be: 1. Undergoing surgical procedure for approved indications for cardiothoracic surgery where a midline sternotomy is planned or 2. VT ablation procedure with epicardial access indicated, or 3. Implant of a subcutaneous ICD 4. Subject must be willing to provide informed consent 5. Subject must be > 18 years old
Exclusion criteria
Exclusion criteria: 1. Subject is considered to be at high risk for infection, 2. Subject has NYHA Class IV, 3. Subject has subcutaneous ICD (S-ICD®) implanted, 4. Subject has an implanted active cardiac or non-cardiac device (e.g., ICD, Pacemaker, Neuro stimulator) that is enabled and can produce electrical stimuli during study procedure 5. Subject at high risk of stroke, Subject is pacemaker dependent 6. Subject had previous pericarditis or prior sternotomy 7. Subject has hiatus hernia or moderate or worse pectus excavatum 8. Subject has significant RV dilation caused by pulmonary hypertension or tricuspid disease 9. Subject has had myocardial infarction within the last 3 months 10. Subject has unstable angina 11. Subject has known skin irritations to the Physio Control Fast-Patch® ECG Electrode 12. Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from a Medtronic study manager 13. Subject has medical conditions that would limit study participation 14. Subject is pregnant 15. Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: Pacing Efficacy 1. Endpoint Definition Subjects will demonstrate a successful pacing outcome if heart capture is observed for at least 3 consecutive beats after pacing stimuli are delivered into at least one out of all tested pacing vectors using pacing current = 20 mA and pacing PW = 10 ms. 2. Analysis Methods The proportion of subjects who have successful pacing outcome will be calculated along with the lower bound of the one-sided 95% confidence interval. The exact method will be used to calculate the lower 95% confidence bound. 3. Determination of Subjects for Analysis All subjects who complete pacing testing according to the CIP will be included in the analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Collection of Sensing Data R-wave amplitude will be summarized using mean and standard deviation for each ECG vector collected via EP recording system for future sensing algorithm development 2. Determine the Degree of Muscle Stimulation During Pacing The degree of muscle stimulation (e.g., high, low, none) will be visually assessed and summarized for each pacing vector collected to provide information about non-cardiac muscle stimulation when pacing | — |
Countries
Canada, United States of America
Contacts
Public ContactMichael Bennett
Outcome results
None listed