User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-7
• Require in-hospital continuous intravenous inotropes
• Have pre-existing cardioversion/defibrillation leads other than those
specified in this investigational plan (unless the investigator intends to
replace them with permitted cardioversion/defibrillation leads)
• Women who are pregnant or not using medically accepted birth control
• Have a mechanical tricuspid prosthesis
• Involved in other cardiovascular clinical investigations of active therapy
or treatment
FOLLOW-UP S CHEDULE
The follow-up schedule for the clinical study consisted of the following
components:
• Pre-impla nt visit–– initial assessment of patient e ligib ility; taking of patient
history.
• Implant––implant of investigational devices and acute device testing.
Randomization status (CRT or No CRT) was assigned for implementation
after a 30-day reco ve ry period.
• Recovery period––minimum 30-day period over which the patient recovered
from the implant procedure and had his/her heart failure medications
adjusted, but with no CRT, regardless of the randomization assignment.
• Post-recovery visit––first visit after the Recovery Period in wh ich patients
underwent Special Testing to establish their baseline condition, after which
the randomization assignment was implemented (CRT or No CRT).
• Three- and six-month visit––evaluation of randomized therapy with Special
Testing and device function at three- and six-months after the post-recovery
visit.
• Quarterly visits––After the six-month visit, patients were seen for routine
evaluation of device function and patient condition.
NOTE: Special Testing included a Symptom-Limited Treadmill Test
with measurement of oxygen uptake (Peak VO
2
), a Six-Minute Walk,
Echocardiography, Holter monitoring, blood chemistry testing, and a Quality
of Life (QOL) questionnaire
- DRAFT -