User Manual Part 4

C-2
CLINICAL STUD Y - DECREASE HF
FOLLOW-UP SCHEDU LE
The follow-up schedule for the DECR EASE HF study is detailed below
(Table C-1 on page C -2).
Table C-1. DECREASE HF follow-up schedule
Follow-up period Follow-up schedule
Pre-implant
Initial assessment of patient eligibility; taking of patient history.
Administration of baseline Quality of Life (QOL) questionnaire.
Implant
Implant of investigational devices and acute device testing.
Two-week visit Physical assessment, including NYHA assessment, and device evaluation.
Special Testing
a
to establish the patient’s baseline condition, aft er which the randomization
assignment was assigned.
Three- and six-month
visit
Evaluation of randomized therapy with Special Testing and device function
b
.
Quarterly visits After the six-month visit, patients were seen for routine evaluation of device function
and patient condition.
a. Special Testing included a Symptom-Limited Treadmill Test with measurement of oxygen uptake (Peak VO
2
), Echocardiography,
QOL questionnaire.
b. Holter monitor recordings were taken at the three-month visit for patients in the Holter Substudy.
INCLUSION/EXCLUSION CRITERIA
Patients enrolled in the investigation were required to meet the following
inclusion criteria:
• Must meet the general indications for a CRT-D implant
• Moderate or severe heart failure, defined as NYHA C lass III-IV desp ite
optimal pharmacologica l hea rt f ailure therapy
• A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to
enrollme nt documenting a sinus rate > 50 bpm, QRS durat ion ≥ 150 ms,
PR interval ≤ 320 ms measured from any two leads and a P-wave duration
< 150 ms measured from lead V
1
• Creatinine ≤ 2.5 mg/dL obtained no mo re than 14 da ys prior to enrollment
• Left ventricular ejection fraction ≤ 35% [measured by echo, multiple gated
acquisition (MU GA) scan, cardiac cat heterization , e tc.] no mo re than 14
days prior to enrollment
- DRAFT -