User Manual Part 4

F-2
CLINICAL STUDY - SUMMARY OF CRT OPTIMIZ
ATION ALGORITHM VALIDATION STUDY
• Patients in AF that can not b e cardioverted for the study
• Sustained, uncontrolled ventricular tachycardia
• Frequent e ctopic activity that makes stable hemodynamic measurements
infeasible
• Sinus rhythm < 30 bpm or > 100 bpm
• Complete AV node block
• Acute severe heart failure exacerbation
• Severeaorticvalvularstenosis(valvearea<1.0squarecm)
• Hypertrophic obstructive cardiomyopathy
• CABG within 2 weeks
• Congenital heart disease
• Pregnancy
• Patient involved in other clinical investigations of active therapy or treatment
• Patient at unacceptably high risk for catheterization (a patient who would
not medically be indicated for an EP study or diagnostic catheterization)
STUDY RESULTS
Patient Accountability
Fifty patients were enrolled in the study. Forty-one patients had valid acute
hemodynamic tests completed and thirty-eight patients had valid echo tests
completed. Among the 9 patients with invalid acute hemodynamic tests, 7
were attempts, and 2 completed the acute test but with invalid results (one of
them had an unstable atrial rate and the other had 2:1 AV conduction). A valid
echo was defined as a subject who had a valid acute hemodynamic test and
also completed the echo test.
Patient Characteristics
The subject demographics are shown below (Table F-1 on page F-3).
- DRAFT -