User Manual
Table Of Contents
- 1. General description
- 2. Indications
- 3. Contraindications
- 4. Warnings and precautions
- 5. Adverse events
- 6. Clinical studies
- 7. Patient selection and treatment
- 8. Patient counselling information
- 9. Conformance to standards
- 10. Physician guidelines
- 11. Patient information
- 12. How supplied
- 13. Device description
- 14. Implant procedure
- 14.1. Necessary equipment
- 14.2. Packaging
- 14.3. Optional equipment
- 14.4. Before opening the package
- 14.5. Prior to implantation
- 14.6. Device placement
- 14.7. Choosing the type of lead
- 14.8. Shock configuration (+ -> -)
- 14.9. Measurement of thresholds at implant
- 14.10. Leads connection
- 14.11. Device implantation
- 14.12. Tests and programming
- 15. Special modes
- 16. Main functions
- 17. Patient follow-up
- 18. Supplemental Information
- 19. Physical characteristics
- 20. Electrical characteristics
- 21. Programmable parameters
- 22. Non programmable parameters
- 23. Limited warranty
- 24. Patents
- 25. Explanation of symbols
6. CLINICAL STUDIES
6.1.5 . Clinical Results V-V timing
V-V programmable settings were available for the clinical study devices as follows: ALTO
MSP model 617 (not programmable for V-V delay), ALTO 2 MSP model 627 values (0, 31,
39, 47, 55 and 63 ms) and OVATIO CRT-D 6750 values (0 to 63 ms in steps of 8 ms).
The graph below shows the programmed V-V settings at randomization by percentage of
patients programmed to each combination of Synchronous BiV pacing and V-V delay.
The optimization protocol in the clinical study specified that each patient randomized should
undergo echo guided V-V optimization. Per the investigational plan for the MSP Clinical
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SORIN – INTENSIA SonR CRT-D 184 – U150A