Heart failure Circulatory System Heart failure
Conditions
Interventions
Subjects indicated for a CRT device will be recruited and implanted with a Model 09108 lead to test for CRT response. ECG Belt, EGM and 12 lead ECG will be collected during multiple pacing maneuvers.
Sponsors
Medtronic, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Indicated for a CRT device system according to local guidelines 2. Implanted with a market-released Medtronic CRT device and a market-released Medtronic LV lead 3. Able to sign and date the study Informed Consent (IC) form 4. 18 years of age or older, or of legal age to give informed consent per local law 5. Subject is willing and able to comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Permanent/persistent AF or presenting with AF with ventricular rate = 90 BPM 2. CIED or has another confounding device (e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator). Insertable cardiac monitors (ICMs) are acceptable. 3. Requires right-sided venous access or a right-sided device implant 4. Contraindication for standard transvenous cardiac pacing (e.g. mechanical right heart valve) 5. History of valve repair or replacement 6. Previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt 7. Post heart transplant (subjects waiting for heart transplants are allowed in the study) 8. Unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days 9. Currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study. 10. Congenital heart disease 11. Hypertrophic cardiomyopathy 12. History of chronic dialysis therapy 13. Less than 1-year life expectancy 14. Pregnant 15. Contraindicated for = 1.0 mg of dexamethasone acetate 16. Subject meets any exclusion criteria required by local law 17. Weighs more than 300 lbs (136 kg) 18. Vulnerable adults
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Characterize the absence of complications related to either the Model 09108 lead implant procedure or the temporarily implanted Model 09108 lead through the first month of follow-up 2. Characterize the proportion of Model 09108 lead implants with ventricular pacing capture at baseline, implant, pre-hospital discharge and 1-month post-implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline, implant, pre-hospital discharge and 1-month post-implant: 1. Characterize the acute CRT response of Ventricle from Atrium (VfA) pacing and traditional CRT using the standard deviation of activation times (SDAT) from the ECG belt technology 2. Characterize the implant success rate of the Model 09108 lead 3. Characterize the resynchronization success rate of the Model 09108 lead via the ECG belt 4. Characterize the voltage pacing capture thresholds, sensing and pacing impedance of the Model 09108 lead at implant 5. Characterize the implant procedure duration | — |
Countries
Australia, Brunei, Hong Kong, Malaysia, Singapore
Contacts
Public ContactJoy Aso
Outcome results
None listed