User Manual Part 4

D-30
CLINICAL STU DY - CONTAK CD
FOCUSED CONFIRMATORY STUDY
Study Design
The Focused Confirmatory Study (FCS) was a prospective, multicenter study
conducted in the United States in 127 patients who participated in an exercise
performance study. The purpose of the FCS was to confirm effectiveness
results related to functional capacity measures, specifically the Peak VO
2
and
6-Minute Hall Walk, previously reported in the NYHA Class III/IV subgroup of
the CONTAK C D Study.
CRT was provided in the same manner for the FCS as for the CONTAK CD
Study. The EASYTRAK lead, along with market approved right atrial and right
ventricular leads were used to provide biventricular stimulation.
Demographic D ata
The patients in the FCS had the same heart failure indications as the patients
in the NYHA Cla ss III/IV subgroup of the CONTAK CD Study; i.e., patient
inclusion criteria included NYHA Class III or IV while on drug therapy, QRS
duration ≥ 120 ms, and Left Ventricular Ejection Fraction (LVEF) ≤ 35%.
A baseline physical assessment and functional measures were performed prior
to CRT system implant. Patients were eligible for participation in the study if
they were capable of walking between 150 and 425 meters. In addition to
a Six-Minute Walk test, other special tests were performed prior to implant
consisting of a symptom-limited treadmill test and completion of the Minnesota
Living with Heart Failure Questionnaire
®
to assess Quality of Life. CRT therapy
was enabled immediately upon device implant. Patients were followed at one
week, one month, three months, six months and every three months thereafter
for a routine physical assessment and device evaluation. Special testing as
defined above was repeated at three months and six months post-implant.
Prior to study entry, patients were stable on optimal heart failure medications
(ACE inhibitors or substitute > 1 month and beta blockers > 3 months). Patients
were excluded if they were indicated for either a pacemaker or ICD or if they
were hospitalized for heart failure in the month prior to enrollment.
The patient characteristics at study entry are summarized in Table D -26 on
page D-31.
- DRAFT -